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NCT01482715 · ClinicalTrials.gov registry record · Phase 1

A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)

A Phase 1 study, sponsored by pharmaand.

Completed
Registry status
Phase 1
Development phase
136
Enrollment target

NCT01482715: Completed Phase 1 study, sponsored by pharmaand.

NCT01482715 is a Phase 1 study that has completed, run by pharmaand. The registered enrollment target is 136 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01482715, a Phase 1 study, has completed, sponsored by pharmaand.

COMPLETED
Registry status
Phase 1
Development phase
136 participants
Enrollment target

Study Summary

Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).

Primary Outcome

The confirmed response rate by RECIST v1.1 is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) on subsequent tumor assessment at least 28 days after first response documentation.

Interventions

  • DRUG Rucaparib

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2011-11
Est. Completion 2019-05
Phase Phase 1
pharmaand

15 total trials

What the finished NCT01482715 record still lists

NCT01482715 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (127% higher).

The record links to 0 conditions, and to 1 intervention - of which Rucaparib is the first listed.

NCT01482715 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01482715 about?

NCT01482715 is a clinical study titled "A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)". Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the sec...

What is the current status of trial NCT01482715?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2011-11. Estimated completion is 2019-05.

What interventions are being tested in trial NCT01482715?

The interventions under investigation include: Rucaparib (DRUG).

Who is sponsoring clinical trial NCT01482715?

This trial is sponsored by pharmaand, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01482715's enrollment target sits among peer trials

136 422nd of 2000 higher than 1,576 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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Source: ClinicalTrials.gov NCT01482715, the US trial registry maintained by the National Library of Medicine. NCT01482715 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.