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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 118 participants.

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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

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT01353625

The ClinicalTrials.gov registry entry for NCT01353625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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

NCT01353625 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.