Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer|
- Number of participants with dose limiting toxicity as assessed by CTCAE v4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Prostate Specific Antigen (PSA) response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|