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

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

Sato Atsushi

Hirosaki University Hospital

53 Honcho, Hirosaki, Aomori

n-arimura@taiho.co.jp

Arimura Naoki

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2113

n-arimura@taiho.co.jp

Recruiting

Aug. 25, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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

Male

CRPC cohort
Metastatic castration-resistant prostate cancer

CRPC cohort
- Feasibility part
Pimitespib in combination with enzalutamide
- Expansion part
Pimitespib in combination with enzalutamide
Or
Enzalutamide

<Pimitespib>
Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment on an empty stomach at least 1 hour before or 2 hours after a meal. The dose used in the Feasibility part will be 160 mg (Level 1) or 120 mg (Level -1). The doses used in Expansion part will be the dose not exceeding maximum tolerable dose (MTD).

<Enzalutamide>
Enzalutamide will be administered orally once daily with starting dose of 160mg.

CRPC cohort
<Feasibility part>
Dose limiting toxicity (DLT) during Cycle 1.

<Expansion part>
Radiographic progression-free survival (rPFS) based on RECIST v1.1 and PCWG3 by the independent radiological review

Adverse event, Adverse drug reaction, Laboratory abnormalities

+81-3-3542-2511

Yes

Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

None