TriangleNCT01344876 · REGISTRY CONDITION SEARCH
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2015-06-08
To determine the maximum tolerated dose (MTD) of OPB-51602
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 20 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
- intervention Names
- Drug: OPB-51602
- label
- OPB-51602
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- OPB-51602
- description
- once daily during the treatment period
- name
- OPB-51602
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 20
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- 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)
- description
- 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).
- measure
- 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)
- secondary Outcomes
- description
- 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.
- measure
- Treatment Response
- time Frame
- From first dose of study medication to withdrawal examination
Full study description
- brief Summary
- To determine the maximum tolerated dose (MTD) of OPB-51602
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-ac4f33094e92ac9566da
- requested nct id
- NCT01344876
- primary nct id
- NCT01344876
- source kind
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- payload
- clinical indication matching status
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- end exclusive
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- id
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- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
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- occurrences
- context exact
- NCT01344876
- end
- 11
- exact text
- NCT01344876
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
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- source json pointer
- /studies/342/protocolSection/identificationModule/nctId
- source kind
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- source record id
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- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 7dcd216034486208c6085fe89748933554a80ad55ed3a69f0f6a98795f9c5ee3
Preserved source evidence · Not medical advice