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NCT02898207 · ClinicalTrials.gov registry record · Phase 1
Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Breast Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 8
- Study locations
NCT02898207: Completed Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Breast Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02898207 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Breast Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02898207, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Recurrent Breast Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back (recurrent). Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
MTD was determined by testing increasing doses of the combination of olaparib PO and onalespib IV within dose escalation cohorts consisting of 3 to 6 evaluable participants. MTD reflects the highest dose combination that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLTs were defined based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Enrollment to this study was suspended prior to completion of the dose escalation due to
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Onalespib
Study Locations (8)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-05-19 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 1 |
What the finished NCT02898207 record still lists
NCT02898207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT02898207 lists 8 locations in 4 states (Massachusetts, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02898207 about?
NCT02898207 is a clinical study titled "Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer". This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube, primary peritoneal, or t...
What is the current status of trial NCT02898207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-05-19. Estimated completion is 2022-01-14.
What conditions does trial NCT02898207 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Recurrent Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma.
What interventions are being tested in trial NCT02898207?
The interventions under investigation include: Olaparib (DRUG), Onalespib (DRUG).
Who is sponsoring clinical trial NCT02898207?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02898207 being conducted?
This trial has 8 study locations across Arizona, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02898207's enrollment target sits among peer trials
28 79th of 92 higher than 13 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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