Stivarga

Gastrointestinal Stromal Tumors, Advance Directives, Liver Cancer + 6 more

Treatment

5 FDA approvals

20 Active Studies for Stivarga

What is Stivarga

Regorafenib

The Generic name of this drug

Treatment Summary

Regorafenib 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.

Stivarga

is 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 body

Regorafenib 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 Risk

The 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 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

47 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?

5

Patient 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.

5

Patient 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.

3.7

Patient 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.

3.7

Patient 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.

1.7

Patient 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!

1

Patient 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.

1

Patient 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.

1

Patient 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.

1

Patient 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.

1

Patient 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 Center

Andrea Borsic, PHD

NE Scientific INC

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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

Image of RJ Zuckerberg in Lake Success, United States.

Nelitolimod for Colorectal Cancer

18+
All Sexes
Lake Success, NY

Nelitolimod is a classC toll-like receptor 9 (TLR9) agonist that binds to TLR9 receptors on myeloid-derived suppressor cells(MDSCs) and helps reshape the tumor microenvironment (TME) and promote antitumor immunity. Investigators hypothesize that Nelitolimod can induce antitumor immune response in CRLM when administered regionally to the liver via a TriNav Pressure Enabled Drug Delivery (PEDD) catheter without compromising surgical feasibility or patient safety. The study objective is to investigate the feasibility and safety of an innovative immunotherapeutic approach for patients with CRLM designed to overcome the immunosuppressive TME in CRLM. Investigators hypothesize that this investigational neoadjuvant treatment will be well tolerated and will not prevent patients from undergoing successful, safe CRLM liver resections. Investigators will assess the safety and feasibility of Nelitolimod given via TriNav PEDD in 10 patients with CRLM prior to liver resection. Patients will receive standard treatment with chemotherapy and then undergo placement of the PEDD catheter. Patients will then receive 3 doses of Nelitolimod before undergoing liver resection.

Phase < 1
Waitlist Available

RJ Zuckerberg

Image of START Midwest in Grand Rapids, United States.

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 Midwest (+2 Sites)

BioNTech Responsible Person

BioNTech SE

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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

Image of University of Oklahoma Health Sciences Center in Oklahoma City, United States.

Multi-Cancer Detection Test for Cancer

45 - 75
All Sexes
Oklahoma City, OK

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).

Recruiting
Has No Placebo

University of Oklahoma Health Sciences Center (+34 Sites)

Scott D Ramsey

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We made a collection of clinical trials featuring Stivarga, we think they might fit your search criteria.
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