Clinical Trials Logo

Clinical Trial Summary

The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).


Clinical Trial Description

This is a first in human, multinational, Phase 1, open-label study of TAS3681 evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC) for which there is no standard therapy. Eligible participants will be enrolled to evaluate safety and determine the MTD/recommended dose for TAS3681, including a preliminary evaluation of food effect and antitumor activity. The study will be conducted in 2 parts, Dose Escalation (Enrollment closed) and Expansion (Enrollment Closed). Patients who are continuing to receive clinical benefit may receive drug in the extension part of the study after escalation and expansion are completed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02566772
Study type Interventional
Source Taiho Oncology, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 2016
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT02495974 - European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Completed NCT03641560 - A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy Phase 4
Terminated NCT02441517 - A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment Phase 4
Active, not recruiting NCT03454750 - Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) Phase 2
Completed NCT03776968 - A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics Phase 1
Completed NCT02471469 - Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
Terminated NCT03177187 - Combination Study of AZD5069 and Enzalutamide. Phase 1/Phase 2
Terminated NCT03531827 - Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment Phase 2
Completed NCT03829436 - TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers Phase 1
Active, not recruiting NCT05241613 - A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 1
Recruiting NCT05369000 - Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT02975934 - A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Phase 3
Active, not recruiting NCT04869488 - A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer Phase 2
Completed NCT00428220 - A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study. N/A
Completed NCT04056754 - Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer Phase 3
Completed NCT03658447 - PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr) Phase 1/Phase 2
Terminated NCT03042312 - Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy Phase 2
Completed NCT02991911 - A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer Phase 1
Completed NCT02655822 - Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers Phase 1
Completed NCT02426333 - Optimizing Abiraterone Therapy