Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer (PROACT)
This study has been completed.
Information provided by (Responsible Party):
First received: September 30, 2010
Last updated: December 14, 2011
Last verified: December 2011
This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer|
Resource links provided by NLM:
Further study details as provided by CytRx:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: At six months. ] [ Designated as safety issue: No ]The primary objective of this study is to determine the preliminary efficacy of administration of bafetinib in subjects with hormone-refractory prostate cancer (HRPC), as measured by the objective response rate (ORR), which is a combination of CR (PSA ≤0.12 ng/mL) and PR (≥50% reduction in PSA from baseline).
Secondary Outcome Measures:
- Safety [ Time Frame: At six months. ] [ Designated as safety issue: Yes ]The safety of bafetinib in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, and vital signs.
- Progression-free survival [ Time Frame: At six months. ] [ Designated as safety issue: No ]Progression-free survival is defined as the time from enrollment to first documentation of objective PSA or tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.
- Objective tumor response [ Time Frame: At six months. ] [ Designated as safety issue: No ]The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria.
|Study Start Date:||August 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Bafetinib 240 mg bid
Other Name: INNO-406
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215799
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
Sponsors and Collaborators
|Study Director:||Daniel Levitt, M.D., Ph.D.||Chief Medical Officer, CytRx Corporation|