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Completed

NCT Number: NCT01344876

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

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

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Key information

Conditions

Multiple Myeloma Acute Lymphoid Leukemia Acute Myeloid Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Vascular Diseases

Age range

20 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPB-51602

Drug

once daily during the treatment period

Primary outcomes

  1. 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)

    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.

  2. 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)

    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).

Secondary outcomes

  1. Treatment Response

    Time frame: From first dose of study medication to withdrawal examination

    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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2011
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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