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PCI-24781 in Combination With Doxorubicin to Treat Sarcoma

NCT01027910 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-24

Study results available
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Summary

The purpose of this research study is to determine the safety and maximum tolerated dose of PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with doxorubicin can overcome chemoresistance to doxorubicin.

Conditions

  • Sarcoma

Interventions

DRUG

PCI-24781

Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

DRUG

Doxorubicin

Administered intravenously on Day 4 of each 3 week cycle

DRUG

GCSF

Administered on Day 5 of each 3 weeks cycle in Arm 1 if determined to be clinically indicated, and in all patients enrolled into Arm 2

Sponsors & Collaborators

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Edwin Choy, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027910 on ClinicalTrials.gov