Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Taiho Oncology, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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
Clareo Health | A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
