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Subprotocol C2 (MET exon 14 deletion/mutation) for Head and Neck Cancers
This trial uses genomic testing to direct cancer treatment. Patients with cancer that has progressed after standard treatment or for which there is no agreed-upon treatment may benefit.
- Head and Neck Cancers
- Lung Cancer
- Bladder Cancer
- Breast Cancer
- Colorectal Cancer
- Liver Cancer
- Multiple Myeloma
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Brain Tumor
- Endometrial Cancer
- Solid Tumors
- Skin Cancer
- Thyroid Cancer
- Esophageal Cancer
- Stomach Cancer
- Kidney Cancer
- Cervical Cancer
- Uterine Cancer
- Gastric Cancer
- Rectal Cancer
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
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Who is running the clinical trial?
- You have started having periods at some point.You have had no signs of any other type of cancer for at least 5 years.You have been treated for basal cell or squamous cell skin cancer and it's under control.You have not had your uterus or ovaries removed, or have not had a natural menopause for at least 24 months (meaning you have had your period at any time in the past 24 months).Requirements for the initial biopsy used to determine if you are eligible for the clinical trial.You must use effective birth control or avoid sex before and during the study, and for 4 months after the study ends. If you or your partner become pregnant during the study, tell your doctor right away.You have a history of a specific type of blood cell disorder called lymphoproliferative disorder.You have had cancer that was actively growing.You have had cancer, except for basal cell carcinoma and squamous cell carcinoma, within the last 5 years.You have heart problems that can lead to abnormal heart rhythms, or you are taking medications that can affect your heart's rhythm.You have been diagnosed with a solid tumor, lymphoma, or multiple myeloma and need treatment for it.You need to provide a sample of your tumor tissue to confirm a specific genetic variation using a special test.You should be able to do most of your daily activities and have a life expectancy of at least 3 months.People with HIV may be allowed to participate if they meet certain requirements.You have already tried standard treatments for your condition and they did not work, or there are no other approved treatments available that can help you.Patients must have specific blood and body chemistry test results within a certain range.You need to have had a heart test within 8 weeks before joining the study, and your heart needs to meet specific health standards.
- Group 1: Subprotocol C2 (MET exon 14 deletion/mutation)
- Group 2: Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)
- Group 3: Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)
- Group 4: Subprotocol Z1M (LAG-3 expression >= 1%)
- Group 5: Subprotocol I (PIK3CA mutation)
- Group 6: Subprotocol A (EGFR activating mutation)
- Group 7: Subprotocol C1 (MET amplification)
- Group 8: Subprotocol B (HER2 activating mutation)
- Group 9: Subprotocol E (EGFR T790M or rare activating mutation)
- Group 10: Subprotocol K1 (FGFR amplification)
- Group 11: Subprotocol T (SMO or PTCH1 mutation)
- Group 12: Subprotocol F (ALK translocation)
- Group 13: Subprotocol P (PTEN loss)
- Group 14: Subprotocol H (BRAF V600E/R/K/D mutation)
- Group 15: Subprotocol L (mTOR mutation)
- Group 16: Subprotocol M (TSC1 or TSC2 mutation)
- Group 17: Subprotocol W (FGFR pathway aberrations)
- Group 18: Subprotocol G (ROS1 translocation or inversion)
- Group 19: Subprotocol J (HER2 amplification >= 7 copy numbers)
- Group 20: Subprotocol R (BRAF fusion or BRAF non-V600 mutation)
- Group 21: Subprotocol Z1F (PIK3CA mutation)
- Group 22: Subprotocol Q (HER2 amplification)
- Group 23: Subprotocol K2 (FGFR mutation or fusion)
- Group 24: Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)
- Group 25: Subprotocol Z1K (AKT mutation)
- Group 26: Subprotocol U (NF2 inactivating mutation)
- Group 27: Subprotocol N (PTEN mutation or deletion and PTEN expression)
- Group 28: Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)
- Group 29: Subprotocol S1 (NF1 mutation)
- Group 30: Subprotocol Y (Akt mutation)
- Group 31: Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)
- Group 32: Subprotocol S2 (GNAQ or GNA11 mutation)
- Group 33: Subprotocol X (DDR2 S768R, I638F, or L239R mutation)
- Group 34: Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)
- Group 35: Subprotocol Z1G (PTEN loss)
- Group 36: Subprotocol Z1H (PTEN mutation)
- Group 37: Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)
- Group 38: Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What prior investigations have included Subprotocol R considerations of BRAF union or non-V600 mutation?
"Presently, 1594 clinical trials are underway to evaluate Subprotocol R (BRAF fusion or BRAF non-V600 mutation), 237 of those being in the last phase. Most studies for this therapy take place in Seattle, Washington but there exist 890 other sites running these experiments."
What is the intake capacity for this clinical research?
"To fulfill the requirements of this trial, 6452 eligible participants must enroll. These patients can join from various medical facilities such as Saint Jude Medical Center in Fullerton, Colorado and Providence Saint Joseph Medical Center/Disney Family Cancer Center situated in Burbank, Idaho."
Are there any vacancies for individuals interested in participating in this research?
"Affirmative. According to the data on clinicaltrials.gov, this medical trial is currently recruiting patients and has been since August 12th 2015. The last update was made on November 30th 2022, with a total of 6452 participants needed from across 100 locations."
How many healthcare establishments are administering this experiment?
"This research is recruiting patients from Saint Jude Medical Center in Fullerton, Colorado, Providence Saint Joseph Medical Center/Disney Family Cancer Center in Burbank, Idaho and Southwest Oncology PC in Durango, Connecticutt Oncoloon, Colorado, Providence Saint Joseph Medical Center/Disney Family Cancer Center in Burbank, Idaho and Southwest Oncology PC in Durango, Connecticut as well as other 100 sites."
What medical conditions are typically treated through Subprotocol R (BRAF fusion or BRAF non-V600 mutation)?
"Subprotocol R (BRAF fusion or BRAF non-V600 mutation) is primarily used to address renal failure but can also be applied for the management of metastatic basal cell carcinoma, inoperable melanoma, and squamous cell carcinomas."
Is Subprotocol R (BRAF fusion or BRAF non-V600 mutation) sanctioned by the FDA?
"Subprotocol R of this trial (BRAF fusion or BRAF non-V600 mutation) was assessed at a score 2 on the safety scale, as there is clinical data confirming its safety but no evidence to back up efficacy yet."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
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