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

NCT01344876 | Completed Phase 1 Results

• 2 other identifiers: 266-10-001JapicCTI-111478
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

multiple myeloma [MM]; non-Hodgkin lymphoma [NHL]; acute myeloid leukemia [AML]; acute lymphoid leukemia [ALL]; chronic myeloid leukemia [CML]

Outcome Measures

Primary Outcomes (2)

• Subjects With Treatment Emergent Adverse Events

  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.

  From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)

• Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

  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).

  From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)

Secondary Outcomes (1)

• Treatment Response

  From first dose of study medication to withdrawal examination

Study Arms (1)

OPB-51602

EXPERIMENTAL

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

Drug: OPB-51602

Interventions

OPB-51602 DRUG

once daily during the treatment period

OPB-51602

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
• Patients who are responsive or have relapsed following standard treatment
• Patients capable of providing written informed consent
• Japanese patients age 20 to 75 years (inclusive) at time of informed consent
• ECOG performance status score of 0-1
• Life expectancy of at least 3 months
• Adequate vital organ function
• 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

You may not qualify if:

• Patients with other primary malignant tumors
• Symptomatic CNS involvement
• Ongoing or active infection, or complication that is not controllable by medication or other means
• Complication of uncontrolled cardiac disease
• Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Leukemia, Lymphoid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Leader of Department of "Small Global" Clinical Development
• Organization: Otsuka Pharmaceutical Co., Ltd

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-05

Locations

JP (2)