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NCT02079740 · ClinicalTrials.gov registry record · Phase 1
Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 2
- Study locations
NCT02079740: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02079740 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02079740, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax inhibits members of the BCL2 family of proteins that are believed to play key roles in promoting the survival of cancer cells. It may stop the growth of cancer cells by blocking Bcl-2, Bcl-XL, and Bcl-w, proteins needed for cancer cell survival. Giving trametinib and navitoclax may help stop the growth of tumor cells.
Primary Outcome
Dose escalation uses a 3+3 enrollment design per dose level. The occurrence of 1 dose limiting toxicity (DLT) will prompt expansion of a given dose level to 6 participants. The occurrence of 2 DLTs in a given dose level will indicate that the maximal tolerated dose (MTD) has been exceeded, and expansion of the prior dose level to 6 participants will occur, if not already performed. The recommended phase 2 dose (RP2D) will be the highest dose level at which no more than 1 out of 6 participants ex
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Navitoclax
Study Locations (2)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2014-03-26 |
| Est. Completion | 2026-03-06 |
| Phase | Phase 1 |
What the registry record for NCT02079740 still lists
NCT02079740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 205-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (53% lower).
The record links to 3 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02079740 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02079740 about?
NCT02079740 is a clinical study titled "Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors". This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic). Trametinib may stop the growth of tumor cells by blocking some of the enzyme...
What is the current status of trial NCT02079740?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2014-03-26. Estimated completion is 2026-03-06.
What conditions does trial NCT02079740 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT02079740?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Navitoclax (BIOLOGICAL).
Who is sponsoring clinical trial NCT02079740?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02079740 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02079740's enrollment target sits among peer trials
96 27th of 92 higher than 66 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
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