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NCT01311713 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Maximum Tolerated Dose of the PARP Inhibitor CEP-9722 in Participants With Solid Tumors
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01311713: Clinical Trial Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01311713 is a Phase 1 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01311713, a Phase 1 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2 (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated dose (MTD) of CEP-9722 administered daily to participants with advanced or metastatic solid tumors, (Part 2) to evaluate the safety and tolerability of that dose, and to investigate whether CEP-9722 has antitumor activity as a single agent.
Primary Outcome
MTD was defined as the highest dose level with 0 or 1 participant experiencing a dose-limiting toxicity (DLT) during cycle 1. DLT was defined as any adverse event (AE) that was considered by the investigator as related or potentially related to CEP-9722 as follows: 1) hematologic: grade 4 hematologic adverse events, grade 3 or greater febrile neutropenia, grade 3 thrombocytopenia lasting 7 days or more, grade 3 thrombocytopenia with bleeding; 2) nonhematologic: grade 3 or 4 nonhematologic AEs; g
Interventions
- DRUG CEP-9722
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-05-02 |
| Est. Completion | 2013-10-16 |
| Phase | Phase 1 |
Why NCT01311713 stopped before completion
NCT01311713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which CEP-9722 is the first listed.
NCT01311713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01311713 about?
NCT01311713 is a clinical study titled "Study to Determine the Maximum Tolerated Dose of the PARP Inhibitor CEP-9722 in Participants With Solid Tumors". CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2 (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated dose (MTD) of CEP-9722 administered daily to participants with advanced or metastatic solid tumors, (Part 2) to evaluate t...
What is the current status of trial NCT01311713?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2011-05-02. Estimated completion is 2013-10-16.
What interventions are being tested in trial NCT01311713?
The interventions under investigation include: CEP-9722 (DRUG).
Who is sponsoring clinical trial NCT01311713?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01311713's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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