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NCT02203513 · ClinicalTrials.gov registry record · Phase 2
A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT02203513: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02203513 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02203513, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study Summary
Background: * All cells go through cycles which allow them to divide. In normal cells, checkpoint kinase 1 (Chk1) and checkpoint kinase 2 (Chk2) (CHEK 2 (Chk1/2) stop cell division at various points to allow any damage to deoxyribonucleic acid (DNA) to be repaired. * When Chk1/2 are not present, cells stop dividing and eventually die. Chk1/2 Inhibitor (Prexasertib (LY2606368) blocks the Chk1/2 proteins. * Researchers hope that by blocking Chk1/2, it will cause tumor cells to die, thereby shrinking tumors. Objective: \- To see if LY2606368 helps shrink tumors in patients with certain breast, ovarian or prostate cancers. Eligibility: \- Participants at least 18 years old with breast or ovarian cancer. They must have a mutation in BRCA1 BReast CAncer gene 1 and BRCA2 BReast CAncer gene 2 (BRCA1/2) genes for group 1, high grade serious ovarian cancer without BRCA1/2 mutation for group 2, or triple negative breast cancer without BRCA1/2 mutation for group 3, or prostate cancer with or without BRCA1/2 mutation for group 4. Design: * Participants will be screened with a medical history and physical exam. They will have blood tests, an electrocardiogram (ECG) heart test, scans, and X-rays. They will have a piece of their tumor removed at entry (computed tomography (CT)-assisted biopsy). * Study Day 1: Participants will have a physical exam and blood drawn. They may have a CT scan of the chest, abdomen, and pelvis. * Day 1 and Day 15 of each 28-day cycle: Participants will receive the study drug through an intravenous (IV). * Vital signs will be checked before and after. An ECG will be done within 1 hour after. * Day 15 and Day 28: Participants will have a physical exam, blood drawn, and a 12 lead ECG. * Cycle 1: Participants will have weekly phone calls and blood draws. Participants may have another CT-assisted biopsy at the end of cycle 1. * Cycle 2 and beyond, blood will be drawn every other week for routine blood tests. * Participants will have an after-study visi
Primary Outcome
Objective response (CR+PR) of single agent Prexasertib (LY2606368) in participants with germline BReast CAncer gene -Mutated (gBRCAm)-associated breast and ovarian cancers, high grade serous ovarian cancer (HGSOC) and triple-negative breast cancer (TNBC) at low genetic risk. Response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of diameters of targ
Interventions
- DRUG LY2606368
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2015-01-20 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 2 |
Why NCT02203513 stopped before completion
NCT02203513 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which LY2606368 is the first listed.
NCT02203513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02203513 about?
NCT02203513 is a clinical study titled "A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer". Background: * All cells go through cycles which allow them to divide. In normal cells, checkpoint kinase 1 (Chk1) and checkpoint kinase 2 (Chk2) (CHEK 2 (Chk1/2) stop cell division at various points to allow any damage to deoxyribonucleic acid (DNA) to be repaired. * When Chk1/2 are not present, ce...
What is the current status of trial NCT02203513?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2015-01-20. Estimated completion is 2021-08-27.
What interventions are being tested in trial NCT02203513?
The interventions under investigation include: LY2606368 (DRUG).
Who is sponsoring clinical trial NCT02203513?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203513's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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