Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02566772|
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration Resistant Prostate Cancer||Drug: TAS3681||Phase 1|
This is a first in human, multinational, phase 1, open-label study of TAS3681 in patients with metastatic castration resistant prostate cancer (mCRPC)evaluating safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with mCRPC for which there is no standard therapy. Eligible patients will either be enrolled in the dose escalation phase to evaluate safety and determine the maximum tolerated dose for TAS3681 or the expansion phase in which additional cohorts of patients may be enrolled to further evaluate safety and preliminary efficacy of TAS3681 at the MTD or at a lower dose.
Approximately 50 evaluable patients will be enrolled in the Dose Escalation Phase and approximately 80 patients will be enrolled in the Expansion Phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2018|
TAS3681 will be provided as 25 mg and 100 mg tablets to be administered QD orally for 28 days, at least 1 hour before or 2 hours after a meal. Number of cycles: approximately 6 or until discontinuation criteria is met, followed by an expansion phase..
TAS3681 will be provided as 25 mg and 100 mg tablets to be administered QD orally for 28 days, at least 1 hour before or 2 hours after a meal. Number of cycles: approximately 6 or until discontinuation criteria is met.
- Number of participants with dose limiting toxicity as assessed by CTCAE v4.0 [ Time Frame: Up to 6 months ]
- Prostate Specific Antigen (PSA) response [ Time Frame: Up to 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566772
|Contact: Takekazu Aoyama, MD, PhDfirstname.lastname@example.org|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Takekazu Aoyama, MD, PhD 609-285-5248 email@example.com|
|Institute of Cancer Research||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5NG|
|Contact: Takekazu Aoyama, MD, PhD +1-609-285-5248 firstname.lastname@example.org|