This study is currently recruiting participants.
Number
002057-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Pregnant Women
Keywords
Combination Therapy; Targeted Therapy; Ras Mutations; MEK Inhibitor; Advanced Solid Tumors
Recruitment Keyword(s)
None
Condition(s)
Neoplasms, Glandular and Epithelial; Colorectal Neoplasms; Melanoma; Pancreatic Neoplasms; Ovarian Neoplasms
Investigational Drug(s)
palbociclib binimetinib
Investigational Device(s)
Intervention(s)
Drug: Binimetinib Drug: Palbociclib
Supporting Site
National Cancer Institute
Cancers that have certain gene mutations are among the most difficult to treat. Mutations in the RAS gene (including KRAS, NRAS, and HRAS), for example, make the cancer cells resistant to most available cancer therapies. Better treatments are needed.
Objective:
To test the drug binimetinib, alone or combined with a second drug, palbociclib, in people with cancers that have RAS mutations.
Eligibility:
People aged 18 years and older who are enrolled in the ComboMATCH protocol. Their cancer must have specific RAS gene mutations. These can include certain ovarian and pancreatic cancers, among others.
Design:
Participants will be screened. They will have blood tests. They will provide a tissue sample (biopsy) of their tumor. If a recent sample is not available, a new biopsy may be done.
Participants will be enrolled in 1 of 4 groups depending on their type of cancer.
Binimetinib and palbociclib are both pills taken by mouth in a 28-day treatment cycle. All participants will take binimetinib 2 times a day for 28 days. Some participants will also take palbociclib once a day for 21 days. They will keep a diary to write down when they take each pill.
All participants will have physical exams and blood tests every 2 weeks during the first 2 cycles. Then they will have blood tests once each month.
Participants may continue receiving treatment for up to 3 years. They will be examined every 12 weeks for 3 years.
Participants will have follow-up visits for up to 3 years after treatment ends. New biopsies and blood may be collected after treatment ends.
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Eligibility: -Participants must be enrolled on the ComboMATCH Master Registration Trial EAY191. -Histologically confirmed cancer for each cohort (with a confirmed RAS mutation via any CLIA certified method when applicable, except for Cohort 2) for which curable treatment modalities are not an option. Participants must have disease that can be safely biopsied and agree to a pre treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191). -Measurable disease per RECIST 1.1 as defined in Section 11.0. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable. All radiologic studies must be performed within 28 days prior to randomization. -Any number of prior therapies permitted. Cohort-specific eligibility: --Cohort 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy. --Cohort 2: No prior receipt of a CDK4/6 inhibitor. --Cohort 3: No prior MEKi/CDK4/6i therapy. --Cohort 4: No prior MEKi/CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit. -No major surgery within 4 weeks (excluding placement of vascular access) of the first dose of study therapy. -No minor surgery within 2 weeks of the first dose of study therapy. -No palliative radiotherapy within 1 week of the first dose of study therapy. -No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment.
-Participants must be enrolled on the ComboMATCH Master Registration Trial EAY191.
-Histologically confirmed cancer for each cohort (with a confirmed RAS mutation via any CLIA certified method when applicable, except for Cohort 2) for which curable treatment modalities are not an option. Participants must have disease that can be safely biopsied and agree to a pre treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191).
-Measurable disease per RECIST 1.1 as defined in Section 11.0. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable. All radiologic studies must be performed within 28 days prior to randomization.
-Any number of prior therapies permitted. Cohort-specific eligibility:
--Cohort 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy.
--Cohort 2: No prior receipt of a CDK4/6 inhibitor.
--Cohort 3: No prior MEKi/CDK4/6i therapy.
--Cohort 4: No prior MEKi/CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit.
-No major surgery within 4 weeks (excluding placement of vascular access) of the first dose of study therapy.
-No minor surgery within 2 weeks of the first dose of study therapy.
-No palliative radiotherapy within 1 week of the first dose of study therapy.
-No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment.
Principal Investigator
Referral Contact
For more information: