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NCT04439201 · ClinicalTrials.gov registry record · Phase 2
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)
A Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04439201: Active Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by National Cancer Institute (NCI).
NCT04439201 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04439201, a Phase 2 study of Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications are present. Researchers hope to learn if palbociclib will shrink this type of cancer or stop its growth.
Primary Outcome
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exa
Conditions Studied
Interventions
- DRUG Palbociclib
Study Locations (1)
Pennsylvania
- ECOG-ACRIN Cancer Research Group - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-05-31 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04439201 still lists
NCT04439201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower).
The record links to 5 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Palbociclib is the first listed.
NCT04439201 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04439201 about?
NCT04439201 is a clinical study titled "Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)". This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications are present. Researchers ...
What is the current status of trial NCT04439201?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2016-05-31. Estimated completion is 2026-12-31.
What conditions does trial NCT04439201 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Lymphoma, Advanced Lymphoma.
What interventions are being tested in trial NCT04439201?
The interventions under investigation include: Palbociclib (DRUG).
Who is sponsoring clinical trial NCT04439201?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04439201 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04439201's enrollment target sits among peer trials
40 61st of 108 higher than 45 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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