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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01344876
First received: April 26, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
Drug: OPB-51602
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The primary objectives of this study are to determine the MTD and safety profile of OPB-51602 in subjects with relapsed or refractory hematologic malignancie. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
    [Safety]DLT, adverse events, body weight, Eastern Cooperative Oncology Group Performance Status, vital signs, 12-lead ECG, pulse oximetry, and laboratory tests [Pharmacokinetics]Plasma concentrations and pharmacokinetic parameters of OPB-51602 and its metabolites


Secondary Outcome Measures:
  • To describe the preliminary efficacy profile of OPB-51602 in subjects with relapsed or refractory hematologic malignancie. [ Time Frame: Leukemia patients will have efficacy and safety evaluated for every month. MM and NHL patients will have efficacy and safety evaluated every 3 months. ] [ Designated as safety issue: No ]
    [Efficacy]Overall response, response (remission) rate, and changes in biomarker


Enrollment: 20
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: OPB-51602
    once daily during the treatment period
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344876

Locations
Japan
Nagoya, Japan
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01344876     History of Changes
Other Study ID Numbers: 266-10-001, JapicCTI-111478
Study First Received: April 26, 2011
Last Updated: May 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
multiple myeloma [MM]
non-Hodgkin lymphoma [NHL]
acute myeloid leukemia [AML]
acute lymphoid leukemia [ALL]
chronic myeloid leukemia [CML]

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Neoplasms by Site

ClinicalTrials.gov processed this record on July 22, 2014