A Safety and Efficacy Study of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Received Prior Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01074138|
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : November 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bone-Metastatic, Castration-Resistant Prostate Cancer||Drug: KX2-391||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||October 2012|
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
- The proportion of patients who do not have clinical or radiographic progression [ Time Frame: 24 weeks ]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 ]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 ]Pharmacokinetic parameters will be determined in patients receiving 40 mg KX2-391, twice daily.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074138
|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|