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NCT01353625 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

A Phase 1 study, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
118
Enrollment target

NCT01353625: Completed Phase 1 study, sponsored by Celgene.

NCT01353625 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 118 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01353625, a Phase 1 study, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 1
Development phase
118 participants
Enrollment target

Study Summary

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

Interventions

  • DRUG CC-115

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2011-04-25
Est. Completion 2021-03-12
Phase Phase 1
Celgene

308 total trials

What the finished NCT01353625 record still lists

NCT01353625 is an interventional study that assigns participants to a tested intervention. The registered 118 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 (97% higher).

The record links to 0 conditions, and to 1 intervention - of which CC-115 is the first listed.

NCT01353625 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01353625 about?

NCT01353625 is a clinical study titled "Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.". The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-st...

What is the current status of trial NCT01353625?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2011-04-25. Estimated completion is 2021-03-12.

What interventions are being tested in trial NCT01353625?

The interventions under investigation include: CC-115 (DRUG).

Who is sponsoring clinical trial NCT01353625?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01353625's enrollment target sits among peer trials

118 499th of 2000 higher than 1,502 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 NCT01353625, the US trial registry maintained by the National Library of Medicine. NCT01353625 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.