Gemzar

Pancreatic Neoplasms, Mesothelioma, Malignant Neoplasms + 15 more

Treatment

14 FDA approvals

20 Active Studies for Gemzar

What is Gemzar

Gemcitabine

The Generic name of this drug

Treatment Summary

Gemcitabine (also known as Gemzar) is a chemotherapy drug used to treat various types of cancer. It works by replacing the building blocks of DNA, which stops tumor growth and causes cancer cells to die. Gemcitabine is approved by the FDA to treat advanced ovarian cancer, metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer. It is administered intravenously and is being studied for other types of cancer as well.

Gemzar

is the brand name

image of different drug pills on a surface

Gemzar Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Gemzar

Gemcitabine

1996

101

Approved as Treatment by the FDA

Gemcitabine, otherwise known as Gemzar, is approved by the FDA for 14 uses including Metastatic Breast Cancer and Advanced Ovarian Cancer .

Metastatic Breast Cancer

Used to treat Metastatic Breast Cancer in combination with Paclitaxel

Advanced Ovarian Cancer

Used to treat Advanced Ovarian Cancer in combination with Carboplatin

stage 4 Pancreatic adenocarcinoma

Pancreatic Adenocarcinoma Locally Advanced

Bladder Transitional Cell Carcinoma Stage IV

Used to treat Bladder Transitional Cell Carcinoma Stage IV in combination with Cisplatin

Urinary Bladder

Used to treat Bladder Transitional Cell Carcinoma Stage IV in combination with Cisplatin

Relapsed Cancer

Used to treat Relapsed Cancer in combination with Carboplatin

Ovarian Neoplasms

Used to treat Advanced Ovarian Cancer in combination with Carboplatin

Pharmacotherapy

Used to treat previous platinum-based chemotherapy in combination with Carboplatin

Pancreatic Neoplasms

Pancreatic Neoplasms

Metastatic Breast Cancer

Used to treat Metastatic Breast Cancer in combination with Paclitaxel

previous adjuvant anthracycline-containg therapy

Used to treat previous adjuvant anthracycline-containg therapy in combination with Paclitaxel

disease progression after chemotherapy

Used to treat disease progression after chemotherapy in combination with Paclitaxel

Effectiveness

How Gemzar Affects Patients

Gemcitabine is a drug used to treat a variety of cancers. It works by blocking cancer cells from making more cells, which can help reduce the size of a tumor. It is usually given as an infusion, which means it is injected over an extended period of time rather than all at once. Clinical trials have shown that gemcitabine can reduce tumor size in patients with advanced non-small cell lung cancer, pancreatic cancer, ovarian cancer, and metastatic breast cancer. However, taking gemcitabine can have some side effects, such as anemia, low white blood cell count, and low platelet count.

How Gemzar works in the body

Gemcitabine is a drug that works to stop cancer cells from reproducing. It does this by blocking the chain of DNA which cancer cells need to reproduce. Gemcitabine works to increase the probability of DNA chain termination by reducing the amount of a certain enzyme which helps cancer cells reproduce. It also prevents the drug from leaving the cell, allowing it to stay active for longer and increase its effectiveness.

When to interrupt dosage

The amount of Gemzar is contingent upon the declared condition, for example Pancreatic Adenocarcinoma Locally Advanced, Metastatic Breast Cancer and Small Cell Lung Cancer. The dosage is contingent upon the approach of delivery (e.g. Powder or Injection, powder, lyophilized, for solution) displayed in the following table.

Condition

Dosage

Administration

Pancreatic Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Head and Neck Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Pharmacotherapy

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Malignant Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Hodgkin Disease

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Carcinoma, Non-Small-Cell Lung

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Relapsed Cancer

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

previous adjuvant anthracycline-containg therapy

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Mesothelioma

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Malignant Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Malignant Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Metastatic Breast Cancer

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

disease progression after chemotherapy

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Ovarian Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Small Cell Lung Cancer

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

CTAGE1 protein, human

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Urinary Bladder

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Pancreatic Neoplasms

, 200.0 mg/mL, 100.0 mg/mL, 40.0 mg/mL, 200.0 mg, 1000.0 mg, 2000.0 mg, 38.0 mg/mL, 10.0 mg/mL

, Injection, powder, lyophilized, for solution, Intravenous, Injection, powder, lyophilized, for solution - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Solution, Solution - Intravenous, Powder, Powder - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous

Warnings

Gemzar Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Gemcitabine may interact with Pulse Frequency

There are 20 known major drug interactions with Gemzar.

Common Gemzar Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Gemcitabine is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Gemcitabine is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Gemcitabine is combined with Abatacept.

Abetimus

Major

The risk or severity of adverse effects can be increased when Gemcitabine is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Gemcitabine is combined with Acteoside.

Gemzar Toxicity & Overdose Risk

The lowest toxic dose of gemcitabine in mice is 333mg/kg, and in rats it is greater than 500mg/kg. When applied to the skin of rabbits, the lowest toxic dose is greater than 1000mg/kg. There is no antidote for gemcitabine overdose, so patients should be monitored for signs of myelosuppression, tingling sensations, and severe rash. Supportive therapy should be given to those who overdose on gemcitabine.

image of a doctor in a lab doing drug, clinical research

Gemzar Novel Uses: Which Conditions Have a Clinical Trial Featuring Gemzar?

333 active studies are currently investigating the potential of Gemzar in providing relief from Small Cell Lung Cancer, Hodgkin Disease and Cervical Cancer.

Condition

Clinical Trials

Trial Phases

Pharmacotherapy

0 Actively Recruiting

Ovarian Neoplasms

9 Actively Recruiting

Phase 2, Phase 1, Not Applicable, Phase 3

Metastatic Breast Cancer

1 Actively Recruiting

Phase 1, Phase 2

Malignant Neoplasms

0 Actively Recruiting

previous adjuvant anthracycline-containg therapy

0 Actively Recruiting

Hodgkin Disease

3 Actively Recruiting

Not Applicable, Phase 1

Pancreatic Neoplasms

15 Actively Recruiting

Phase 1, Phase 2, Early Phase 1, Not Applicable

Malignant Neoplasms

0 Actively Recruiting

Mesothelioma

0 Actively Recruiting

Malignant Neoplasms

4 Actively Recruiting

Phase 1, Phase 2

Pancreatic Neoplasms

0 Actively Recruiting

Urinary Bladder

0 Actively Recruiting

Small Cell Lung Cancer

50 Actively Recruiting

Phase 2, Phase 3, Phase 1, Not Applicable, Early Phase 1

CTAGE1 protein, human

13 Actively Recruiting

Phase 1, Not Applicable, Phase 2, Early Phase 1, Phase 3

Head and Neck Neoplasms

6 Actively Recruiting

Phase 3, Not Applicable, Phase 1

disease progression after chemotherapy

0 Actively Recruiting

Relapsed Cancer

8 Actively Recruiting

Phase 1, Phase 2

Carcinoma, Non-Small-Cell Lung

23 Actively Recruiting

Phase 2, Phase 1, Not Applicable, Phase 3

Gemzar Reviews: What are patients saying about Gemzar?

5

Patient Review

7/22/2014

Gemzar for Breast Cancer that has Spread to Another Part of the Body

Following an allergic reaction to Docetaxil, I began a new regimen of carbo/gemzar/w Benadryl & anti nausea med. Six months later, my breast tumors are gone. I have had low blood counts for the last two months, but Procrit has helped me feel better. My gemzar is given in two doses a week apart followed by IV /w magnesium & potassium the next week, then a week off (bloodwork) and the cycle starts again. To avoid constipation from the anti-nausea meds, I eat fruit after each treatment.

5

Patient Review

6/30/2015

Gemzar for Non-Small Cell Lung Cancer

I was looking at death short-term, and now I'm a year out with only a handful of tumors remaining. This treatment really turned things around for me.

5

Patient Review

6/16/2021

Gemzar for Breast Cancer that has Spread to Another Part of the Body

I am so pleased with how well Gemzar has worked for me. My cancer markers have decreased significantly, and the spots are visibly smaller.

4.3

Patient Review

1/21/2014

Gemzar for Breast Cancer that has Spread to Another Part of the Body

I'm feeling good so far. My blood cell counts have been low, but my doctor hasn't had me take anything for that yet; they just lowered my doses to 50 and 75 percent. I've got my first CAT scan coming up this Friday, and fingers crossed it's working because I don't mind the treatment otherwise.

3.7

Patient Review

9/11/2010

Gemzar for Non-Small Cell Lung Cancer

I have been taking this medicine for a little while now and it has been working well for me. I haven't had any problems and I am generally satisfied with it.

3.3

Patient Review

9/25/2012

Gemzar for Cancer of the Ovary

The Gemzar/Carbo combination really helped with my cancer, but it was tough on my platelets. I took a break for three months and have since seen the cancer progress, but can't go back on this regimen. Other than the issues with my platelets, I had no problems while taking this medication.

3.3

Patient Review

4/21/2014

Gemzar for Cancer of the Pancreas

I've been on this medication for over a year now. When I first started, it was very tolerable; however, as time has gone on, the side effects have become more pronounced. I've lost all of my body hair, and I'm dealing with mild anemia and peripheral neuropathy.

3.3

Patient Review

9/24/2010

Gemzar for Cancer of the Pancreas

I've been on Gemsar for a few months now and, though I have had to miss some treatments due to low blood counts/platelets, it seems to be doing its job. The only real side effects I've noticed are diarrhea, poor appetite, and cramps; nothing too major.

3

Patient Review

6/22/2011

Gemzar for Non-Small Cell Lung Cancer

After treatment, I have experienced severe swelling in my knees and ankles. It's very painful and makes it difficult to walk. This lasts for about three days. does anyone else experience this?

3

Patient Review

1/31/2010

Gemzar for Non-Small Cell Lung Cancer

2.7

Patient Review

2/7/2010

Gemzar for Cancer of the Pancreas

2.3

Patient Review

4/24/2012

Gemzar for Non-Small Cell Lung Cancer

My husband has been taking this for 3 months and his last ct scan showed a decease in size of the tumor. He does not get any side effects and is tolerating it well so far. He has been on several chemo drugs and I hope this will get the cancer under control.

2.3

Patient Review

10/12/2012

Gemzar for Cancer of the Pancreas

I've been struggling with ovarian cancer for three years now, and it's only gotten worse. The nausea is almost constant, and I've lost twenty pounds since August. chemo doesn't seem to be working, and I'm not sure how much more of this I can take.

2.3

Patient Review

10/22/2012

Gemzar for Cancer of the Pancreas

This was a tough course. I got pneumonia three times and even had to go to the hospital for renal failure once. With each treatment, my fever would get as high as 103 degrees. Finally, we decreased the dose by 20% and that seems to have helped with the reactions. The tumor was removed by surgery but they still recommended chemo for six months.

2.3

Patient Review

2/19/2022

Gemzar for malignant tumor or cancer

My husband tragically passed away after taking this medication. He started off seemingly okay, but then his hemoglobin and platelet levels dropped dangerously low. TTP developed twice; the second time also caused kidney failure.

1.7

Patient Review

8/29/2012

Gemzar for Breast Cancer that has Spread to Another Part of the Body

My mother seems to be allergic to this drug, unfortunately. While it did shrink the tumor, the high activity level remains. After treatments she experiences shortness of breath, weakness, and panic attacks from a lack of air. She's taken antibiotics and prednizone for the breathing difficulties but they don't seem to help; I think it's the gemzar that's causing these negative reactions.

1.7

Patient Review

8/2/2018

Gemzar for Cancer of the Pancreas

This treatment led to severe suppression of my blood cells, which caused kidney failure and other serious health problems. I'm now on dialysis and may need it for the rest of my life. If I had known about the potential risks, I would never have taken this drug.

1.3

Patient Review

4/19/2014

Gemzar for Breast Cancer that has Spread to Another Part of the Body

Unfortunately, this medication did not seem to have any effect on the growth of my cancer cells, based on blood tests and a PET-CT scan.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about gemzar

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can Gemzar cure cancer?

"Gemcitabine is a chemotherapy drug used to treat various types of cancer by slowing or stopping the growth of cancer cells."

Answered by AI

How long can you take Gemzar?

"The typical course of treatment for gemcitabine consists of several cycles spaced out over a period of 21 to 28 days, with each cycle lasting for one week of treatment followed by one week of rest."

Answered by AI

How effective is Gemzar?

"Patients treated with Taxotere and Gemzar had a 47% chance of surviving for at least one year, compared to 42% for those treated with Platinol and vinorelbine. However, both groups of patients had a similar chance of surviving without their cancer progressing for four months."

Answered by AI

What type of chemo is Gemzar?

"Gemzar is a drug that is used to treat cancer. It works by interfering with the way cancer cells grow."

Answered by AI

Clinical Trials for Gemzar

Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

Ruxolitinib for T-Cell Lymphoma

18+
All Sexes
Columbus, OH

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Phase 2
Recruiting

Ohio State University Comprehensive Cancer Center

Jonathan Brammer, MD

Incyte Corporation

Image of Henry Ford Cancer- Detroit in Detroit, United States.

SG + Immunotherapy for Lung Cancer

18+
All Sexes
Detroit, MI

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination. The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors. Participants in the trial will: * receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient. * CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks. * provide tissue (optional) and blood for additional testing (learn about the cancer).

Phase 2
Waitlist Available

Henry Ford Cancer- Detroit

Gilead Sciences

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Image of Ocala Oncology Center /ID# 278269 in Ocala, United States.

ABBV-706 + Atezolizumab for Small Cell Lung Cancer

18+
All Sexes
Ocala, FL

Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide. In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Phase 2
Recruiting

Ocala Oncology Center /ID# 278269 (+1 Sites)

ABBVIE INC.

AbbVie

Image of NEXT Oncology in San Antonio, United States.

PF-08046876 for Bladder Cancer

18+
All Sexes
San Antonio, TX

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.

Phase 1
Recruiting

NEXT Oncology (+11 Sites)

Pfizer CT.gov Call Center

Pfizer

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Image of National Institutes of Health Clinical Center in Bethesda, United States.

CCR4 CAR T Cells for T-Cell Lymphoma

18 - 120
All Sexes
Bethesda, MD

Background: Chemokine receptor 4 (CCR4) is a protein that is found on the surface of certain T-cell lymphoma cells and is common in mature T-cell cancers. White blood cells can be changed with molecules called anti-CCR4 to express a chimeric antigen receptors (CAR), which is a molecule that directs a white blood cell to attack other cells. The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own white blood cells modified to target cancer cells. More research is needed to find out if gene therapy can treat T-cell cancers and do it safely. Objective: To test safety of giving people with certain mature T-cell lymphomas their own white blood cells modified with anti-CCR-4 CAR. Eligibility: People aged 18 and older with certain mature T-cell lymphomas that have not responded to or have come back after treatment. They must have a T-cell lymphoma that has CCR4 on the surface of the cancer cells. Design: Participants will be screened. They will have a medical history and physical exam. Tests of blood, urine, and heart and lung function will be done. Participants will have tests: Computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging scans: They will lie on a table that slides into a donut-shaped machine or a tube. Pictures of the inside of the body will be taken. Before the PET scan, they will get an injection of radioactive fluid in a vein in the arm. Before the MRI, they may get a contrast dye injected through a vein (IV) in the arm. A biopsy of the tumor may be taken. A bone marrow sample may be taken from the hip: The area will be numbed and a large needle inserted through the skin. Leukapheresis will be done to obtain T-cells that will be genetically modified to express anti-CCR4 CARs on T-cells: Blood is drawn through an IV in one arm, circulated through a machine, and then returned through an IV in the other arm. Chemotherapy drugs will be given in an IV to prepare the body to accept the modified CAR T cells. The modified cells will be given in an IV. Participants will be followed for 15 years: This will require blood tests over the first 1-2 years followed by yearly visits and possibly telehealth updates....

Phase 1
Recruiting

National Institutes of Health Clinical Center

Samuel Y Ng, M.D.

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