A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy
The standard of care for patients with bone-metastatic, castrate-resistant prostate cancer is chemotherapy. If a patient elects not to choose chemotherapy, 70% will progress within 6 months. KX2-391 given orally twice a day for 6 months will be evaluated for its ability to delay/prevent disease progression in patients who have not had prior chemotherapy.
Bone-Metastatic, Castration-Resistant Prostate Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-Label, Single-Arm Study Evaluating the Safety, Efficacy and Pharmacokinetics of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Had Prior Chemotherapy|
- The proportion of patients who do not have clinical or radiographic progression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]At screening/baseline, target lesions will be identified and measured by CT scan and bone lesions will be enumerated by bone scintigraphy. At 12 and 24 weeks after treatment with KX2-391, patients will be assessed by CT and bone scan to assess whether radiographic progression has occurred. At monthly visits and throughout the study, clinical progression will be evaluated.
- Determine the proportion of patients who do not have PSA progression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]PSA will be measure at baseline and at the start of each of 6, 28 day cycles
- Determine the pharmacokinetics of KX2-391 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Pharmacokinetc parameters will be determined in patients receiving 40 mg KX2-391, twice daily.
|Study Start Date:||February 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Subjects will be enrolled into a 28-day dose-escalation study. If no DLT's are observed during the first 28 days, subjects are eligible to continue treatment in the Extension Phase and can remain on treatment until toxicity occurs or until disease progression.
KX2-391 will be administered as a 40 mg oral dosing solution, twice daily, for 6 28-day cycles.
Other Name: KXO1
This is a multi-center, single-arm, open-label, prospective phase II clinical trial evaluating the efficacy, safety and pharmacokinetics of orally administered KX2-391 in adult male patients with progressive bone-metastatic CRPC. Patients must have 1) documented bone-metastatic prostate cancer, 2) castrate levels of testosterone, 3) not received prior chemotherapy, and 4) documented disease progression based on rising PSA, progressive measurable visceral disease and/or progressive bone lesions (one criteria is sufficient) as per the Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines (Scher et al 2008).
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|United States, Michigan|
|Wayne State University-Karmanos Cancer Center|
|Detroit, Michigan, United States|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Michael Carducci, MD||Johns Hopkins University|
|Study Director:||Min-Fun Rudolf Kwan, MD||Kinex Pharmaceuticals|