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NCT05554367 · ClinicalTrials.gov registry record · Phase 2
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
A Phase 2 study of Malignant Solid Neoplasm and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT05554367: Active Phase 2 study of Malignant Solid Neoplasm and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT05554367 is a Phase 2 study of Malignant Solid Neoplasm and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 199 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05554367, a Phase 2 study of Malignant Solid Neoplasm and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.
Primary Outcome
Will compare the PFS distributions between those treated with palbociclib and binimetinib vs. binimetinib alone. PFS will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median PFS, and estimated PFS rates at 6, 12, 18, 24, and 30 months will be estimated along with corresponding 95% confidence intervals. A log-rank test will be used to compare the PFS distributions between the two treatment arms in this cohort. In an ancillary manner, Cox proportional ha
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- DRUG Binimetinib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UF Health Cancer Institute - Gainesville - Gainesville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Colorado
- UCHealth University of Colorado Hospital - Aurora
- Poudre Valley Hospital - Fort Collins
- Cancer Care and Hematology-Fort Collins - Fort Collins
- UCHealth Greeley Hospital - Greeley
- Medical Center of the Rockies - Loveland
California
- UC San Diego Health System - Encinitas - Encinitas
- UC San Diego Moores Cancer Center - La Jolla
- VA Palo Alto Health Care System - Palo Alto
- UC San Diego Medical Center - Hillcrest - San Diego
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2026-08-26 |
| Phase | Phase 2 |
What the registry record for NCT05554367 still lists
NCT05554367 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (83% lower).
The record links to 5 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05554367 names 20 study sites across 6 states, led by Florida, Colorado, California.
Frequently Asked Questions
What is clinical trial NCT05554367 about?
NCT05554367 is a clinical study titled "Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial". This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signa...
What is the current status of trial NCT05554367?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2023-12-13. Estimated completion is 2026-08-26.
What conditions does trial NCT05554367 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Stage IV Pancreatic Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Exocrine Pancreas Carcinoma, Ovarian Low Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT05554367?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Binimetinib (DRUG).
Who is sponsoring clinical trial NCT05554367?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05554367 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05554367's enrollment target sits among peer trials
199 69th of 176 higher than 108 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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