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

Phase 1

Completed

• Conditions: Multiple Myeloma; Non-Hodgkin Lymphoma; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia
• Interventions: Drug: OPB-51602

• Registration Number: NCT01344876
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-08
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Results First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Subjects With Treatment Emergent Adverse Events	From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)	Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)	DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).

Secondary Outcome Measures

Name	Time	Method
Treatment Response	From first dose of study medication to withdrawal examination	Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia.; "Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment.