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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 20, 2015
Last verified: May 2015

April 26, 2011
May 20, 2015
April 2011
April 2014   (final data collection date for primary outcome measure)
  • Subjects With Treatment Emergent Adverse Events [ Time Frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) ] [ Designated as safety issue: Yes ]
    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).
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
Complete list of historical versions of study NCT01344876 on ClinicalTrials.gov Archive Site
Treatment Response [ Time Frame: From first dose of study medication to withdrawal examination ] [ Designated as safety issue: No ]

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.

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
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
Experimental: OPB-51602
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
Intervention: Drug: OPB-51602
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2014
April 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01344876
266-10-001, JapicCTI-111478
No
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
May 2015

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