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Tyrosine Kinase Inhibitor
Rogaratinib for Sarcoma and Gastrointestinal Stromal Tumors
Phase 2
Waitlist Available
Led By Suzanne George
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after removal from study
Awards & highlights
Study Summary
This trial studies the effect of rogaratinib in treating patients with sarcoma with a change in FGFRs or SDH-deficient GIST. Rogaratinib may stop growth of tumor cells by blocking enzymes needed for cell growth.
Who is the study for?
Adults with advanced sarcoma showing FGFR alterations or SDH-deficient GIST, not suitable for surgery. Must have measurable disease, acceptable organ function, and be willing to undergo a biopsy if safe. Excludes those with certain viral infections unless treated, pregnant women, and individuals on medications that interact with Rogaratinib.Check my eligibility
What is being tested?
The trial is testing Rogaratinib's effectiveness in halting tumor growth by blocking enzymes needed for cell growth in patients with specific protein changes in their sarcomas or who have a particular type of GIST.See study design
What are the potential side effects?
While the document does not specify side effects of Rogaratinib, similar cancer drugs can cause fatigue, nausea, liver issues, risk of infection due to low blood counts and potential heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after removal from study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after removal from study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective radiographic response
Secondary outcome measures
Incidence of adverse events
Progression-free survival
Other outcome measures
Banking of tumor material, germline deoxyribonucleic acid, and peripheral blood
Mechanisms of resistance
Serial measurements of FGFR and FGFR ligand
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (rogaratinib)Experimental Treatment6 Interventions
Patients receive rogaratinib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline and progression and CT, MRI, and PET-CT every 8 weeks. Patients may also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2008
Completed Phase 2
~2210
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,718 Previous Clinical Trials
40,963,343 Total Patients Enrolled
456 Trials studying Sarcoma
230,641 Patients Enrolled for Sarcoma
Suzanne GeorgePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
2 Previous Clinical Trials
61 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My sarcoma has an FGFR alteration, is advanced or has spread, and cannot be removed by surgery.I am 18 years old or older.You are not currently taking any experimental drugs or treatments.I am not taking any medications that affect my heart's electrical cycle.My calcium and phosphate levels are normal.I have been cancer-free for over 5 years, except for certain skin cancers or cervical pre-cancer.I can take care of myself but might not be able to do heavy physical work.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am allergic to medications similar to rogaratinib.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am not pregnant and have had a negative pregnancy test recently.I finished my cancer treatment more than 2 weeks ago, or 6 weeks ago for specific drugs.I am HIV positive, on treatment that doesn't interact with CYP3A4, and my viral load has been undetectable for 6 months.I am not taking any drugs that strongly affect how my body processes certain medications.I agree to use effective birth control during and for 4 months after the study.My hepatitis B virus load is undetectable with treatment.My brain scans show no worsening after treatment for brain metastases.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am not pregnant or breastfeeding.I have recovered from side effects of previous cancer treatments, except for hair loss.My cancer has worsened after one standard chemotherapy treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (rogaratinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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