Gemcitabine Hydrochloride

Pancreatic Neoplasms, Mesothelioma, Malignant Neoplasms + 15 more

Treatment

14 FDA approvals

20 Active Studies for Gemcitabine Hydrochloride

What is Gemcitabine Hydrochloride

Gemcitabine

The Generic name of this drug

Treatment Summary

Gemcitabine is a chemotherapy drug used to treat many types of cancer, including ovarian, breast, lung, and pancreatic cancer. It works by replacing the building blocks of nucleic acids, which helps to stop the growth and spread of cancer cells. Gemcitabine is sold under the brand name Gemzar and is administered intravenously. It is approved by the FDA to treat advanced ovarian cancer, metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer. It is also being studied for use with other types of cancer.

Gemzar

is the brand name

image of different drug pills on a surface

Gemcitabine Hydrochloride 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 Gemcitabine Hydrochloride Affects Patients

Gemcitabine is a medication used to treat cancer. It works by blocking the progress of cells through the G1/S-phase boundary, and encourages malignant cells to die (apoptosis) while they are undergoing DNA synthesis. Studies have shown that it can be effective against a variety of cancers, and works best when given over a long period of time as opposed to a high dose. Gemcitabine's effects have been seen in clinical trials for non-small cell lung cancer, pancreatic cancer, head and neck cancer, breast cancer, colon cancer, and bladder cancer. It has been found to be effective in

How Gemcitabine Hydrochloride works in the body

Gemcitabine is a drug that stops cancer cells from reproducing. It is converted into active metabolites that stop DNA from forming properly. This prevents the cancer cells from replicating, leading to cell death. Gemcitabine also has self-potentiating effects, which increase the chances of it successfully stopping DNA formation. It reduces the metabolism of active metabolites in the cancer cells, allowing them to remain in the cell at a high concentration for longer.

When to interrupt dosage

The proposed measure of Gemcitabine Hydrochloride is reliant upon the determined condition, including Pancreatic Adenocarcinoma Locally Advanced, Metastatic Breast Cancer and Small Cell Lung Cancer. The dosage fluctuates according to the delivery technique (e.g. Powder or Injection, powder, lyophilized, for solution) featured in the table beneath.

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

Gemcitabine Hydrochloride 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 Gemcitabine Hydrochloride.

Common Gemcitabine Hydrochloride 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.

Gemcitabine Hydrochloride Toxicity & Overdose Risk

The lowest toxic dose of gemcitabine for mice is 333mg/kg, and for rats is greater than 500mg/kg. Rabbits have a dermal LD50 of more than 1000mg/kg. If a patient experiences an overdose of gemcitabine, they may experience myelosuppression, tingling sensations, and a severe rash. It is important to monitor blood counts and provide supportive care, as necessary. There is no known antidote for gemcitabine overdose.

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

Gemcitabine Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Gemcitabine Hydrochloride?

333 ongoing investigations are examining the potential of Gemcitabine Hydrochloride to treat 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

Gemcitabine Hydrochloride Reviews: What are patients saying about Gemcitabine Hydrochloride?

5

Patient Review

8/19/2015

Gemcitabine Hydrochloride for Cancer of the Ovary

I've just started this treatment, so it's too early to give a full review. So far, though, I'm optimistic.

5

Patient Review

4/21/2012

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

This was my first time using this drug, in combination with carbo and test. I had some standard side effects but nothing too bad. The tumor reduction after the first scan was better than expected.

5

Patient Review

11/17/2014

Gemcitabine Hydrochloride for Non-Small Cell Lung Cancer

I didn't have any issues when taking this drug as directed. The only thing I noticed was some mild irritation in my veins.

4.7

Patient Review

4/28/2011

Gemcitabine Hydrochloride for Cancer of the Pancreas

My mom has been taking this medication for seventeen months and it's been great. Only recently has she begun having real issues like fluid in her lungs, shortness of breath, congestive heart disease, and fatigue. She was diagnosed back in July 2009, but unfortunately the cancer is inoperable.

4.3

Patient Review

4/17/2009

Gemcitabine Hydrochloride for Cancer of Gallbladder or Bile Ducts

Worked when Doxil failed. It halted the progression of my grandmother's platinum resistant cancer.

3.7

Patient Review

5/31/2010

Gemcitabine Hydrochloride for Cancer of the Pancreas

My husband has been on gemcitabine for 11 months now. The most significant side effects have been fatigue and recently low blood counts.

3.7

Patient Review

8/5/2008

Gemcitabine Hydrochloride for Cancer of the Ovary

My mother was on this drug for ovarian cancer and she developed an irregular heart beat from the medication which caused her to throw a blood clot and have a stroke.

3.3

Patient Review

12/10/2010

Gemcitabine Hydrochloride for Cancer of the Pancreas

The patient is taking this medication for pancreatic cancer with lymphatic involvement and metastases to the liver and gallbladder.

3

Patient Review

2/28/2009

Gemcitabine Hydrochloride for Cancer of the Ovary

I'm on my fifth round of this drug and so far it's been going well. I don't find the gemcitabine to be difficult to take at all, which is a relief compared to the docetaxel. The only downside seems to be lower blood counts, but that's manageable.

2.3

Patient Review

9/26/2011

Gemcitabine Hydrochloride for Cancer of the Bladder

I was supposed to have this treatment six times, but my red blood count got too low so I could only make it every other week. I felt good while doing it, though very tired. It was easy to fall asleep during the treatment.

2.3

Patient Review

11/15/2016

Gemcitabine Hydrochloride for Non-Small Cell Lung Cancer

I got very sick from this medication and ended up hospitalized with pneumonia. I'm still not entirely better.

2.3

Patient Review

9/24/2007

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

2

Patient Review

6/18/2008

Gemcitabine Hydrochloride for Cancer of the Ovary

I experienced severe nausea and found it easy to get infections while taking this drug. I never felt good while on it and, unfortunately, my cancer has progressed since 2004.

1

Patient Review

2/18/2013

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

I was extremely unhappy with this treatment. It gave me hot and cold sweats, back spasms and pain.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about gemcitabine hydrochloride

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

Is gemcitabine a chemotherapy?

"Gemcitabine is a cancer-treating drug that can be used alone or with other drugs, depending on the type of cancer. It is sometimes used with radiotherapy treatment."

Answered by AI

What class of chemotherapy is gemcitabine?

"The nucleobase is bonded to the sugar's 1′ carbon atom whereas the phosphate(s) of a nucleotide are bonded to the sugar's 3′ and/or 5′ carbons.

Nucleosides are molecules that can be thought of as nucleotides without a phosphate group. A nucleoside consists of a nucleobase and a five-carbon sugar whereas a nucleotide is composed of a nucleobase, a five-carbon sugar, and one or more phosphate groups. The nucleobase is bonded to the sugar's 1 carbon atom whereas the phosphate(s) of a nucleotide are bonded to the sugar's 3 and/or 5 carbons."

Answered by AI

Is gemcitabine an immunotherapy or chemo?

"Gemcitabine is a chemotherapy drug used to treat mesothelioma and other forms of cancer, such as non-small cell lung cancer and soft-tissue sarcoma."

Answered by AI

What is gemcitabine hydrochloride used for?

"Gemcitabine is used to treat non-small cell lung cancer that has spread to other parts of the body and cannot be treated with surgery in combination with cisplatin."

Answered by AI

Clinical Trials for Gemcitabine Hydrochloride

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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