NCT01667133 - A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 2, 2018

Study Completion Date

August 2, 2018

Conditions

Chronic Myeloid Leukemia (CML)Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Interventions

DRUG

ponatinib - Phase 1

30 mg dose of ponatinib taken orally once daily for at least the first 6 patients. If no dose-limiting toxicities are observed, the next patients will receive 45 mg dose of ponatinib taken orally once daily. Once the recommended dose is confirmed, all patients may receive the recommended dose, at the investigators' discretion.

DRUG

ponatinib - Phase 2

Recommended dose of ponatinib as determined in the dose escalation phase. In addition, 3 patients will receive 15 mg dose once daily for 8 days for PK testing. These PK patients may be allowed to receive the recommended dose after PK testing is complete, at the investigators' discretion.

Trial Locations (11)

464-8681

Aichi Cancer Center Hospital, Nagoya

010-8543

Akita University Hospital, Akita

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima

Unknown

Kyushu University Hospital, Hukuoka-shi

The Cancer Institute Hospital Japanese Foundation for Cancer Research, Koto

The University of Tokyo, The Institute of Medical Science, Minato-ku

Keio University Hospital, Shinjuku-ku

Osaka City University Hospital, Shinjuku-ku

National Cancer Center Hospital, Chuo-ku, Tokyo

Tokyo Medical University Hospital, Shinjuku-ku, Tokyo

589-8511

Kinki University Hospital, Faculty of Medicine, Osakasayama-shi