Phase 1 Completed N=20 Treatment

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

Multiple Myeloma · Non-Hodgkin's Lymphoma · Acute Myeloid Leukemia · leukemia

Source: ClinicalTrials.gov NCT01344876 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Jun 2015

Primary outcomePrimary: Subjects With Treatment Emergent Adverse Events — 20 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjects With Treatment Emergent Adverse Events	20	—
PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0; 0; 0; 0; 1	—
SECONDARY Treatment Response	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01344876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.