A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer (NCT04586270) | Clinical Trial Compass
TerminatedPhase 1
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
Stopped: Taiho Oncology as the sponsor of study TAS0612-101, has made a strategic decision to terminate the TAS0612-101 study, taking into consideration the safety profile of TAS0612 and the absence of encouraging anti-tumor activity.
United States, France47 participantsStarted 2020-10-15
Plain-language summary
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 discontinue…
What they're measuring
1
Dose Limiting Toxicities (DLTs)
Timeframe: Baseline through Cycle 1 (28-day cycle)
2
rPFS rate
Timeframe: Baseline through measured progressive disease (estimated up to 12 months)