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NCT01526928 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
A Phase 1 study, sponsored by Clovis Oncology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 612
- Enrollment target
NCT01526928: Clinical Trial Phase 1 study, sponsored by Clovis Oncology.
NCT01526928 is a Phase 1 study that was terminated before completion, run by Clovis Oncology. The registered enrollment target is 612 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (920% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526928, a Phase 1 study, was terminated before completion, sponsored by Clovis Oncology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 612 participants
- Enrollment target
Study Summary
Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.
Primary Outcome
Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have r
Interventions
- DRUG Rociletinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2012-03-27 |
| Est. Completion | 2018-08-27 |
| Phase | Phase 1 |
Why NCT01526928 stopped before completion
NCT01526928 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (920% higher).
The record links to 0 conditions, and to 1 intervention - of which Rociletinib is the first listed.
NCT01526928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526928 about?
NCT01526928 is a clinical study titled "Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients". Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of o...
What is the current status of trial NCT01526928?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 612 participants. The study started on 2012-03-27. Estimated completion is 2018-08-27.
What interventions are being tested in trial NCT01526928?
The interventions under investigation include: Rociletinib (DRUG).
Who is sponsoring clinical trial NCT01526928?
This trial is sponsored by Clovis Oncology, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526928's enrollment target sits among peer trials
612 24th of 2000 higher than 1,976 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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