Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

Otsuka

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Non-Hodgkin Lymphoma

Treatments: Drug: OPB-51602

Study type: Interventional

Funder types: Industry

Identifiers

NCT01344876

JapicCTI-111478 (Other Identifier)

266-10-001

Details and patient eligibility

About

To determine the maximum tolerated dose (MTD) of OPB-51602

Enrollment: 20 patients

Sex: Male

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
2. Patients who are responsive or have relapsed following standard treatment
3. Patients capable of providing written informed consent
4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent
5. ECOG performance status score of 0-1
6. Life expectancy of at least 3 months
7. Adequate vital organ function
8. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration

Exclusion criteria

1. Patients with other primary malignant tumors
2. Symptomatic CNS involvement
3. Ongoing or active infection, or complication that is not controllable by medication or other means
4. Complication of uncontrolled cardiac disease
5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
6. Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

OPB-51602

Experimental group

Description:

OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

Treatment:

Drug: OPB-51602