Phase 2 platform study of combination therapy with pimitespib in patients with malignant tumors

Phase 2 platform study evaluating combination therapy with TAS-116 (pimitespib) in patients with malignant tumors - CHAPTER-Platform-201

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230263

Enrollment

Registered

2023-08-25

Start date

2023-08-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRPC cohort Metastatic castration-resistant prostate cancer

Interventions

CRPC cohort - Feasibility part Pimitespib in combination with enzalutamide - Expansion part Pimitespib in combination with enzalutamide Or Enzalutamide Pimitespib will be administered orally in 5 con

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Castration-resistant prostate cancer (CRPC) cohort - Provided written informed consent - Histologically confirmed prostatic cancer - Had the treatment with novel hormone agent (NHA) as the most recent previous treatment - CRPC or metastatic hormone-sensitive prostate cancer previously treated with one NHA - Documented disease progression during treatment with NHA as the most recent therapy 1.Progression of PSA: PSA value increased in two or more consecutive measurements taken at intervals of one week or more, and the increase in PSA value was >=1 ng/mL or more (based on PCWG3). 2.Progression of soft tissue lesions: Judged as progression of disease according to the definition of RECIST v1.1. 3.Progression of bone lesions: Two or more new lesions appeared on bone scintigraphy (based on PCWG3). - Naive to chemotherapy (cytotoxic anticancer drugs, etc) and Ra-223 as treatment for metastatic CRPC - Have at least one evaluable lesion per RECIST v1.1 and/or bone metastatic disease detected by bone scintigraphy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion criteria

Exclusion criteria: CRPC cohort - A serious illness or medical condition - Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study - QTcF interval >470 msec at baseline

Design outcomes

Primary

Measure	Time frame
CRPC cohort Dose limiting toxicity (DLT) during Cycle 1. Radiographic progression-free survival (rPFS) based on RECIST v1.1 and PCWG3 by the independent radiological review	—

Secondary

Measure	Time frame
Adverse event, Adverse drug reaction, Laboratory abnormalities	—

Contacts

Public ContactNaoki Arimura

Taiho Pharmaceutical Co., Ltd.

n-arimura@taiho.co.jp+81-3-3293-2113

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026