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

NCT ID: NCT01344876

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-04-30

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPB-51602

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

Group Type: EXPERIMENTAL

OPB-51602

Intervention Type: DRUG

once daily during the treatment period

Interventions

OPB-51602

once daily during the treatment period

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya, , Japan

Tokyo, , Japan

Countries

Japan

Other Identifiers

JapicCTI-111478

Identifier Type: OTHER

Identifier Source: secondary_id

266-10-001

Identifier Type: -

Identifier Source: org_study_id