Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
This study is currently recruiting participants.
Verified May 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01344876
First received: April 26, 2011
Last updated: May 14, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Multiple Myeloma
U.S. FDA Resources
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
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations 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 14, 2013 |
| 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 May 16, 2013