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PCI-24781 in Combination With Doxorubicin to Treat Sarcoma

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ClinicalTrials.gov Identifier: NCT01027910
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : February 14, 2017
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Pharmacyclics LLC.
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Interventions Drug: PCI-24781
Drug: Doxorubicin
Drug: GCSF
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PCI-24781 + Doxorubicin Without Mandatory GCSF PCI-24781 + Doxorubicin With Mandatory GCSF
Hide Arm/Group Description

PCI-24781 + Doxorubicin without mandatory GCSF

PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle

PCI-24781 + Doxorubicin with mandatory GCSF

PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle

Period Title: Overall Study
Started 6 14
Completed 6 14
Not Completed 0 0
Arm/Group Title PCI-24781 + Doxorubicin Without Mandatory GCSF PCI-24781 + Doxorubicin With Mandatory GCSF Total
Hide Arm/Group Description Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established. Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established. Total of all reporting groups
Overall Number of Baseline Participants 6 14 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 14 participants 20 participants
52  (14) 56  (14) 54  (14)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 14 participants 20 participants
Female
1
  16.7%
7
  50.0%
8
  40.0%
Male
5
  83.3%
7
  50.0%
12
  60.0%
1.Primary Outcome
Title Maximum Tolerated Dose
Hide Description [Not Specified]
Time Frame up to 30 days after starting study drugs
Hide Outcome Measure Data
Hide Analysis Population Description
The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.
Arm/Group Title PCI-24781 + Doxorubicin Without Mandatory GCSF PCI-24781 With Mandatory GCSF
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 14
Measure Type: Number
Unit of Measure: mg/m2
15 45
2.Secondary Outcome
Title Dose Limiting Toxicities
Hide Description number of patients who experienced dose limiting toxicities
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optional GCSF Mandatory GCSF
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 14
Measure Type: Number
Unit of Measure: participants
2 2
3.Secondary Outcome
Title Number of Partial Responses (PR)
Hide Description number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optional GCSF Mandatory GCSF
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 14
Measure Type: Number
Unit of Measure: participants
0 3
4.Secondary Outcome
Title Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optional GCSF Mandatory GCSF
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 14
Measure Type: Number
Unit of Measure: participants
1 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCI-24781+Dox Without Mandated GCSF PCI-24781+Dox With Mandated GCSF
Hide Arm/Group Description Patients in this arm were not mandated treatment with GCSF Patients in this are were mandated treatment with GCSF
All-Cause Mortality
PCI-24781+Dox Without Mandated GCSF PCI-24781+Dox With Mandated GCSF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PCI-24781+Dox Without Mandated GCSF PCI-24781+Dox With Mandated GCSF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      2/14 (14.29%)    
Blood and lymphatic system disorders     
grade 3 or 4 neutropenia  0/6 (0.00%)  0 2/14 (14.29%)  2
thrombocytopenia  1/6 (16.67%)  1 0/14 (0.00%)  0
Infections and infestations     
infection  1/6 (16.67%)  1 0/14 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PCI-24781+Dox Without Mandated GCSF PCI-24781+Dox With Mandated GCSF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/14 (0.00%)    
Gastrointestinal disorders     
diarrhea  1/6 (16.67%)  1 0/14 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Edwin Choy
Organization: Massachusetts General Hospital
Phone: 617-724-4000
Publications:
Responsible Party: Edwin Choy, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01027910     History of Changes
Other Study ID Numbers: 09-352
First Submitted: December 8, 2009
First Posted: December 9, 2009
Results First Submitted: March 9, 2016
Results First Posted: February 14, 2017
Last Update Posted: February 14, 2017