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NCT02159989 · ClinicalTrials.gov registry record · Phase 1
Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT02159989: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02159989 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 83 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02159989, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept in treating patients with solid tumors that have come back (recurrent) and have spread to another place in the body (metastatic) or cannot be removed by surgery (unresectable). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ziv-aflibercept may stop the growth of solid tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving sapanisertib with ziv-aflibercept may kill more tumor cells.
Primary Outcome
DLTs were defined as adverse events per Common Terminology Criteria for Adverse Events version 4.0, related to study agents and fulfilling one of the following criteria: Hematologic * Grade 4 neutropenia for \> 7 days * Febrile neutropenia (defined as absolute neutrophil count \[ANC\] \< 1.0 x 109/L and fever ≥ 38.5° C) or grade ≥3 infection with ANC≤1.0 x 109/L. * Platelet count \< 25,000/mm for \> 7 days Non-hematologic * Any toxicity ≥grade 3 that persists for \> 7 days, except: 1. nause
Conditions Studied
Interventions
- DRUG Sapanisertib
- BIOLOGICAL Ziv-Aflibercept
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2014-06-18 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 1 |
What the finished NCT02159989 record still lists
NCT02159989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (53% lower).
The record links to 8 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Sapanisertib is the first listed.
NCT02159989 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02159989 about?
NCT02159989 is a clinical study titled "Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept in treating patients with solid tumors that have come back (recurrent) and have spread to another place in the body (metastatic) or cannot be removed by surgery (unresectable). Sapanisertib may stop the gro...
What is the current status of trial NCT02159989?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2014-06-18. Estimated completion is 2024-01-29.
What conditions does trial NCT02159989 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Ovarian Carcinoma.
What interventions are being tested in trial NCT02159989?
The interventions under investigation include: Sapanisertib (DRUG), Ziv-Aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT02159989?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02159989 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02159989's enrollment target sits among peer trials
83 30th of 108 higher than 79 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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