Stivarga

Gastrointestinal Stromal Tumors, Advance Directives, Liver Cancer + 6 more
Treatment
5 FDA approvals
20 Active Studies for Stivarga

What is Stivarga

RegorafenibThe Generic name of this drug
Treatment SummaryRegorafenib is a pill used to treat metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and liver cancer. It was approved by the FDA in 2012 and later in 2017 it was approved to treat liver cancer as well. Regorafenib works by blocking certain proteins in the body that are involved in tumor growth.
Stivargais the brand name
image of different drug pills on a surface
Stivarga Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Stivarga
Regorafenib
2012
1

Approved as Treatment by the FDA

Regorafenib, also called Stivarga, is approved by the FDA for 5 uses which include unresectable Gastrointestinal stromal tumor and Metastatic Gastrointestinal Stromal Tumor .
unresectable Gastrointestinal stromal tumor
Metastatic Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Tumors
Advance Directives
Gastrointestinal Stromal Tumors

Effectiveness

How Stivarga works in the bodyRegorafenib is a drug that works by blocking the activity of certain proteins in the body. These proteins are involved in normal cell functions, but can also cause cancer, create new blood vessels to feed tumors, and help maintain the environment in which a tumor grows. In lab tests, regorafenib has been shown to stop these proteins from working, and in animal models, it has been seen to reduce tumor growth and spread.

When to interrupt dosage

The endorsed dose of Stivarga is contingent upon the diagnosed ailment, such as oxaliplatin, previously treated with anti-VEGF and unresectable Gastrointestinal stromal tumor. The magnitude of dosage is contingent upon the approach of administration (e.g. Tablet or Tablet, film coated - Oral) specified in the table beneath.
Condition
Dosage
Administration
Gastrointestinal Stromal Tumors
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
Advance Directives
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
Liver Cancer
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
oxaliplatin
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
sorafenib
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
Gastrointestinal Stromal Tumors
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
RAS wild-type with previous of anti-EGFR therapy
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
previously treated with anti-VEGF
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral
Colorectal Cancer
40.0 mg,
Oral, Tablet - Oral, , Tablet, Tablet, film coated, Tablet, film coated - Oral

Warnings

There are 20 known major drug interactions with Stivarga.
Common Stivarga Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Regorafenib.
Axitinib
Major
The serum concentration of Axitinib can be increased when it is combined with Regorafenib.
Belinostat
Major
The metabolism of Belinostat can be decreased when combined with Regorafenib.
Bendamustine
Major
The serum concentration of Bendamustine can be increased when it is combined with Regorafenib.
Binimetinib
Major
The serum concentration of Binimetinib can be increased when it is combined with Regorafenib.
Stivarga Toxicity & Overdose RiskThe most common side effects of taking this drug are exhaustion/tiredness, difficulty speaking, diarrhea, loss of appetite, high blood pressure, mouth ulcers, throat pain, pain elsewhere in the body, weight loss, stomach or abdominal pain, rash, fever, and nausea.
image of a doctor in a lab doing drug, clinical research

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

177 active trials are currently being conducted to investigate the potential of Stivarga to ameliorate RAS wild-type with previous history of anti-EGFR therapy, Liver Cancer and Metastatic Gastrointestinal Stromal Tumors.
Condition
Clinical Trials
Trial Phases
Liver Cancer
17 Actively Recruiting
Phase 2, Phase 4, Phase 1, Not Applicable, Phase 3
sorafenib
0 Actively Recruiting
Gastrointestinal Stromal Tumors
0 Actively Recruiting
previously treated with anti-VEGF
0 Actively Recruiting
RAS wild-type with previous of anti-EGFR therapy
0 Actively Recruiting
Colorectal Cancer
46 Actively Recruiting
Phase 2, Phase 1, Phase 3, Not Applicable, Early Phase 1
Advance Directives
0 Actively Recruiting
Gastrointestinal Stromal Tumors
0 Actively Recruiting
oxaliplatin
0 Actively Recruiting

Stivarga Reviews: What are patients saying about Stivarga?

5Patient Review
1/28/2013
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
So far, so good. The scans have been positive and I'm responding well to the medication. I get sick if I take more than the prescribed dosage, so I stick to three pills. I'll be back for more scans in a few weeks.
5Patient Review
9/26/2018
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
I've been on this medication for over a year and a half now, trying Lonsurf first but seeing only minimal results. This treatment has much fewer side effects than chemotherapy (which I never ended up doing), though there is some fatigue and foot pain. Despite that, it's kept my CEA levels low.
3.7Patient Review
5/21/2017
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
I have a needle phobia, so many cancer treatments are out of the question for me. This oral medication is much easier to take, and I've only been on it for two weeks. So far the most notable side effects are fatigue and some mild soreness in my hands and feet, but those could improve with time or may be unrelated to the drug entirely.
3.7Patient Review
8/14/2015
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
I'm on my third cycle of this treatment, and I've noticed that my CEA numbers have increased.
1.7Patient Review
5/18/2016
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
I can't believe the FDA would approve something like this. It's torture!
1Patient Review
8/8/2015
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
Please, do not take this medication. It's incredibly dangerous and can lead to liver failure in a short amount of time--even if you only take the recommended dosage. My father experienced liver failure as a direct result of taking this drug. Please explore other options with naturopaths who offer vitamin C IV treatments.
1Patient Review
8/8/2015
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
Do not take srivatsan. It is incredibly dangerous and can lead to liver failure in a few weeks, especially if you are older and have to take 4 pills a day. My father had liver failure because of this drug. Do not take your chances with it.
1Patient Review
1/31/2020
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
The side effects were really severe. I had a four-hour nosebleed and lost feeling and use of my left arm and leg. It was honestly pretty scary, and I'm still recovering weeks later.
1Patient Review
10/23/2022
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
I absolutely do not recommend this medication. My husband started taking it and 2 weeks later he was in liver failure. He passed away 3 weeks after starting the medicine.
1Patient Review
11/25/2016
Stivarga for Colon and Rectal Cancer that has Spread to Another Area
My spouse died as a result of taking this drug, which caused hyperbilirubemia, hepatotoxicity and extreme high blood pressure.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about stivarga

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

What is the success rate of Stivarga?

"over the course of the study.

Patients who took STIVARGA had an improved overall survival rate, living a median of 10.6 months compared to those taking placebo who only lived a median of 7.8 months. There were 233 deaths out of 379 patients with STIVARGA (62%) vs 140 deaths out of 194 patients with placebo (72%) over the course of the study."

Answered by AI

Is Stivarga chemotherapy?

"A targeted therapy is a type of cancer treatment that targets the changes in cancer cells that help them grow, divide, and spread. The trade name for the generic chemotherapy drug regorafenib is Stivarga®. In some cases, the generic name regorafenib may be used by health care professionals when referring to the trade name Stivarga®. Stivarga® is a targeted therapy; a type of cancer treatment that targets changes in cancer cells that enable their growth, division, and spread."

Answered by AI

Can Stivarga cure cancer?

"Stivarga works by inhibiting the growth of cancer cells by blocking the enzymes that promote cancer growth, including those in the vascular endothelial growth factor pathway."

Answered by AI

Is Stivarga a last resort?

"The drug regorafenib was approved last year as third line treatment for patients with advanced Gastrointestinal Stromal Tumor. Gastrointestinal stromal tumor (GIST) is a rare type of cancer found in the digestive system, most often in the wall of the stomach."

Answered by AI

Clinical Trials for Stivarga

Image of Dartmouth HItchcock Medical Center in Lebanon, United States.

Computer-Assisted Microwave Ablation for Liver Cancer

18 - 90
All Sexes
Lebanon, NH
The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults. The employed software calculates and displays a simulation of the ablation such that the physician can visualize what portion of the target tumor has, and has not been treated at any point during the procedure. The main questions it aims to answer are: 1) Does the use of the computer guidance software reduce the number of times a tumor is incompletely treated. 2) Does the use of the computer guidance software reduce the rate of local tumor recurrence at 2 year follow-up? 3) Was there an increase or a decrease in medical problems for participants after a procedure where the guidance software was used? Researchers will compare liver tumor treatment using the computer guidance software with an historic control to see if the addition of the guidance software improved the outcomes after an ablation. Participants will: Undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation. Visit the clinic at one month and then every 3 months for blood tests and a contrast-enhanced CT or MRI imaging study (as per standard of care)
Waitlist Available
Has No Placebo
Dartmouth HItchcock Medical CenterAndrea Borsic, PHDNE Scientific INC
Image of University of Kentucky in Lexington, United States.

Hepatic Artery Infusion Chemotherapy for Liver Cancer

18 - 99
All Sexes
Lexington, KY
The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are: * safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver) * help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital Participants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center. The main treatment on study will last about 3-4 months.
Phase 2
Waitlist Available
University of KentuckyMichael Cavnar, MD
Image of RJ Zuckerberg in Lake Success, United States.

Implantable Microdevice for Colorectal Cancer

18+
All Sexes
Lake Success, NY
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.
Phase < 1
Waitlist Available
RJ Zuckerberg
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BNT314 + BNT327 + Chemotherapy for Colorectal Cancer

18+
All Sexes
Grand Rapids, MI
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.
Phase 1 & 2
Recruiting
START MidwestBioNTech Responsible PersonBioNTech SE
Image of University of Hawai'i Cancer Center in Honolulu, United States.

Ipilimumab + Nivolumab with SBRT for Liver Cancer

18+
All Sexes
Honolulu, HI
Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses. NHPI patients are also underrepresented in clinical trials, limiting the relevance of treatment advances for this population. The standard treatment for HCC is surgical resection; however, many NHPI patients present with unresectable disease. Recent advances with immune checkpoint inhibitors (ICIs), such as nivolumab and ipilimumab, have shown promise in treating advanced HCC and improving survival in previously untreatable cases. Additionally, stereotactic body radiotherapy (SBRT) has been shown to enhance survival and local control when combined with systemic therapies like ICIs. However, without surgery, outcomes remain suboptimal, with response rates for ICIs alone at 20-30%, and combination ICI-SBRT treatment showing slightly better results but still a high risk of progression. Despite improvements in HCC treatment, significant gaps remain in managing borderline resectable disease, especially in NHPI patients. This study aims to evaluate the safety and efficacy of combining ICIs and SBRT with curative surgery for patients with borderline resectable HCC, focusing on NHPI populations. The study will also explore the use of biomarkers such as cell-free DNA (cfDNA), CD8+ T-cell infiltration, and serum cytokine markers to guide personalized treatment strategies. Preliminary findings suggest that this multimodal approach may improve outcomes and enable surgical resection for patients previously considered inoperable. This study seeks to address the unmet need for effective treatment strategies in borderline resectable HCC and to improve survival outcomes for underserved NHPI populations.
Phase 1
Waitlist Available
University of Hawai'i Cancer CenterJared D Acoba, MD
Image of Juravinski Hospital in Hamilton, Canada.

Radiation and Immunotherapy for Liver Cancer

18+
All Sexes
Hamilton, Canada
The objectives of this study is to estimate the biological activity of combination chemotherapy and radiation versus radiation alone in patients with Hepato Cellular Carcinoma (HCC). The study hypothesizes is that combination chemotherapy and radiation is superior to radiation alone in inducing a biological response. The study hypothesizes that combination chemotherapy and radiation is superior to radiation alone in inducing a biological response. A biological response, or change in the tumor microenvironment (TME), is defined by reduced infiltration of intra-tumoral regulatory T cells (Tregs), a decrease in tumour-associated macrophages (TAMs) of the M2 phenotype, and an increase in immune cells such as effector CD8+ T-cells. An increased rate of biological response is therefore expected in participants receiving the combination of Durvalumab, Tremelimumab, and stereotactic body radiation therapy (SBRT), compared to those receiving SBRT alone. Additionally, biological response is hypothesized to correlate with pathological response. The study has been conducted within a WOO window of opportunity randomized clinical trial in order to obtain data in the quickest and safest manner. Patients undergoing surgery are very healthy by definition and will be able to tolerate treatment without any major complications, leading to adequate tissue samples before and after treatment.
Phase 3
Waitlist Available
Juravinski Hospital
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Portal + Hepatic Vein Embolization for Liver Cancer

18+
All Sexes
Montreal, Canada
The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.
Recruiting
Has No Placebo
Centre Hospitalier de l'Université de Montréal (+18 Sites)
Image of University of Alabama at Birmingham in Birmingham, United States.

ProAgio for Colorectal Cancer

18+
All Sexes
Birmingham, AL
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.
Phase 1
Recruiting
University of Alabama at BirminghamMidun Malla, MD
Have you considered Stivarga clinical trials? We made a collection of clinical trials featuring Stivarga, we think they might fit your search criteria.Go to Trials
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