Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02566772|
Recruitment Status : Unknown
Verified August 2016 by Taiho Oncology, Inc..
Recruitment status was: 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 ]
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): 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|