A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
20 Years
75 Years
Male
Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
Trial Information
A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Description:
[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
Outcome Time Frame:
1 Month
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
266-10-001
NCT ID:
NCT01344876
Start Date:
April 2011
Completion Date:
December 2013
Related Keywords:
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Chronic Myeloid Leukemia
- multiple myeloma [MM]
- non-Hodgkin lymphoma [NHL]
- acute myeloid leukemia [AML]
- acute lymphoid leukemia [ALL]
- chronic myeloid leukemia [CML]
- 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
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