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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:
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
History of Changes

April 26, 2011
May 14, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01344876 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)

To determine the maximum tolerated dose (MTD) of OPB-51602
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Acute Myeloid Leukemia
  • Acute Lymphoid Leukemia
  • Chronic Myeloid Leukemia
Drug: OPB-51602
once daily during the treatment period
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
20 Years to 75 Years
No
Contact: Mitsuo Hamamoto +81-06-6943-7722
Japan
 
NCT01344876
266-10-001, JapicCTI-111478
No
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP