A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

Phase 1TerminatedNCT04586270

Taiho Oncology, Inc.47 enrolled

Overview

The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Tumors

Interventions

TAS0612DRUG

oral tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Dose Escalation: Have histologically confirmed, locally advanced, and unresectable cancer, or metastatic cancer and have progressed on or were intolerant to standard treatments or refused standard of care (SOC). Dose Expansion: Have documented histologically or cytologically confirmed adenocarcinoma of the prostate with documented PTEN loss or loss of function mutation, who have metastatic castration-resistant disease and have: * Disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3)/modified RECIST 1.1 after the most recent regimen. * Received androgen receptor directed therapy previously with or without chemotherapy consisting of no more than 2 prior taxane-based regimens. * Been receiving androgen deprivation therapy with serum testosterone \<50 ng/dL (\<2.0 nM). Note: previously documented PTEN loss or loss of function mutation from archived tissue sample testing or cfDNA sample testing is acceptable if done in a CLIA certified lab or a locally certified lab. Have an ECOG score of 0 or 1 Dose Escalation (Part 1): Have no measurable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Dose Expansion (Part 2): Have measurable or no measurable disease per PCWG3/modified RECIST 1.1 • No more than 30 patients with no measurable disease will be enrolled in Dose Expansion (Part 2). Exclusion Criteria: * Participating in medical research not compatible with this study * Have not discontinued or recovered from previous treatments for cancer * Have a significant cardiac condition * Have untreated brain metastases * Have a primary brain tumor * Have a serious concomitant disorder * Unable to swallow or digest pills * Poorly controlled diabetes * Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study

Locations (4)

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Institut Paoli Calmette

Marseille, Bouches Du Rhone, France

Centre de Lutte Contre le Cancer Gustave Roussy

Villejuif, Val De Marne, France

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLTs)

Number of participants with DLTs during cycle 1

Time frame: Baseline through Cycle 1 (28-day cycle)

rPFS rate

Percentage of participants with partial response (PR) or complete response (CR) at 6 months Prostate Cancer Working Group 3 (PCWG3)/ modified defined by the Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1.

Time frame: Baseline through measured progressive disease (estimated up to 12 months)

Secondary Outcomes

Disease Control Rate (DCR) per PCWG3/mRECIST1.1

DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.

Time frame: Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months.

Duration of Response (DOR) per PCWG3/mRECIST1.1

DOR: Date of PR or CR to date of objective progression or death due to any cause.

Time frame: Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months.

Radiographic Progression Free Survival (rPFS) per PCWG3/mRECIST1.1

Proportion of patients experiencing a radiographic progression by PCWG3/mRECIST1.1 criteria

Time frame: Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 6 months.

Overall Response Rate (ORR) per PCWG3/mRECIST1.1

Proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR)

Time frame: Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months.

Data from ClinicalTrials.gov

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