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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344876
• Other study ID #: 266-10-001
• Secondary ID: JapicCTI-111478
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2011
• Last updated: May 20, 2015
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• OPB-51602
once daily during the treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects With Treatment Emergent Adverse Events	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.	From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)	Yes
Primary	Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	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).	From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)	Yes
Secondary	Treatment Response	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.	From first dose of study medication to withdrawal examination	No