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Kinase Inhibitor
Vemurafenib + Copanlisib for Thyroid Cancer
Phase 1
Waitlist Available
Led By Alan L Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tissue from the primary tumor or metastases available for correlative studies
Able to swallow and retain an orally administered pill without any clinically significant gastrointestinal abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is studying a new drug combo to treat BRAF-mutant thyroid cancers & increase sensitivity to radioiodine therapy.
Who is the study for?
This trial is for adults with thyroid cancer of follicular origin (like papillary or poorly differentiated subtypes) that have a BRAF V600 mutation and haven't had recent treatment. They must be able to take pills, agree to biopsies, have RAIR disease, measurable tumor growth, good performance status, and meet lab value criteria. Pregnant individuals, those with certain medical conditions or on prohibited meds can't join.Check my eligibility
What is being tested?
The study tests combining two drugs—Vemurafenib and Copanlisib—to see if they can make radioiodine therapy more effective in shrinking tumors resistant to it in patients with BRAF-mutant thyroid cancers. It also aims to find the highest safe doses of these drugs when used together.See study design
What are the potential side effects?
Potential side effects from Vemurafenib and Copanlisib may include digestive issues, liver problems, fatigue, rash or other skin changes, increased risk of infections due to immune system effects; specific side effect profiles will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tissue samples from my cancer available for study.
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I can swallow pills without any major stomach or intestine problems.
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I am mostly able to care for myself and carry out daily activities.
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My condition is resistant to standard treatments.
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My tumor has a BRAF V600 mutation.
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My thyroid cancer is confirmed and originates from follicular cells.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of vemurafenib plus copanlisib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with thyroid cancerExperimental Treatment3 Interventions
Eligible participants will have a diagnosis of BRAF mutant RAIR thyroid cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
I-124 PET/CT lesion dosimetry
2020
Completed Phase 1
~10
Copanlisib
2016
Completed Phase 2
~130
Vemurafenib
2015
Completed Phase 3
~3100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,847 Total Patients Enrolled
Alan L Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills without any major stomach or intestine problems.I have tissue samples from my cancer available for study.I am not using highly effective birth control methods.I take medication for seizures.I am a man and will use a condom during treatment and for 6 months after.You have a positive test for cytomegalovirus (CMV) at the start of the study.I have a history of bleeding disorders or unexplained bleeding.I am mostly able to care for myself and carry out daily activities.My condition is resistant to standard treatments.My tumor has a BRAF V600 mutation.Your test results meet certain requirements.I cannot follow a low-iodine diet or need medication high in iodide.I have been diagnosed with HIV.I have brain tumors that have not been treated.I was diagnosed and treated for another cancer within the last 2 years.I am not taking any medications that are not allowed in this study.My thyroid cancer is confirmed and originates from follicular cells.I have a wound, ulcer, or bone fracture that hasn't healed.People with certain heart and blood sugar problems.I haven't received thyroid cancer treatment recently.I have not had a clot or embolism recently.I am taking more than 15 mg of prednisone or its equivalent daily.I do not have any serious infections.I have a lung condition or my lungs don’t work very well.You have hepatitis B or C virus infection.My cancer can be measured by scans and has grown after radiation.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with thyroid cancer
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the typical indications for Copanlisib treatment?
"Copanlisib is frequently prescribed as a remedy for Erdheim-Chester Disease. It has also been used to address metastatic melanoma, non-small cell lung carcinoma, lymphomas and various cases of follicular malignancy."
Answered by AI
What is the upper bound on participants for this experiment?
"Affirmative. Clinicaltrials.gov provides evidence to suggest that this clinical trial is actively seeking participants, which was first posted on June 26th 2020 and most recently edited on March 3rd 2022. It requires 32 patients from 7 enrolment sites."
Answered by AI
What are the current regulatory opinions regarding Copanlisib?
"Although limited studies have been conducted to assess its safety and efficacy, Copanlisib received a score of 1 on our scale."
Answered by AI
What other research initiatives have been undertaken examining Copanlisib's effects?
"In 2012, Copanlisib's clinical use first began at James Graham Brown Cancer Center-University of Louisville. Since then there have been 71 completed trials and 74 ongoing studies, the majority originating from Harrison New jersey."
Answered by AI
Are additional participants being sought out for this research endeavor?
"Clinicaltrials.gov currently indicates that the trial is recruiting patients, which began on June 26th 2020 and was revised March 3rd 2021."
Answered by AI
Could you provide a list of the medical centers running this clinical research in our city?
"Presently, the clinical trial has 7 operational sites located in Harrison, Basking Ridge and Commack as well as other cities. To reduce travel expenses associated with enrolment, it is beneficial to select a clinic closest to you."
Answered by AI
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