Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer

NCT01423903 | Completed Phase 1

• 1 other identifier: 266-09-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.

Conditions

Advanced Cancer

Keywords

Phase I; STAT-3 inhibitor; solid tumors

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of OPB-51602

  AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.

  Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).

Secondary Outcomes (3)

• To determine the pharmacokinetics of OPB-51602 and to determine the MTD of OPB-51602

  28 days

• Pharmacodynamic profile:

  28 days

• Antitumor effects:

  Every 2 cycles (on average 8 weeks).

Study Arms (1)

OPDC-51602

EXPERIMENTAL

Subjects with advanced solid tumors will be treated with OPDC-51602 once daily by mouth

Drug: OPB-51602

Interventions

OPB-51602 DRUG

A cycle will consist of 28 days of OPB-51602 be taken by study subjects daily by mouth for every day of each 28 day cycle.

OPDC-51602

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 18 years
• Pathologically confirmed advanced cancer that is resistant or refractory to standard therapy or for which no standard curative therapy is available
• At least 4 weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agent.
• Subjects must have recovered from adverse effects of prior therapy at time of enrollment to ≤ Grade 1 (excluding alopecia)
• ECOG performance status ≤ 1
• Life expectancy of ≥ 3 months following study entry
• Adequate organ function, defined as follows:
• Serum creatinine \< 1.5 x the upper limit of normal (ULN)
• Aspartate aminotransferase and alanine aminotransferase levels ≤ 3.0 x ULN (≤ 5.0 x ULN in the presence of known liver metastasis)
• Total bilirubin ≤ 1.5 x ULN
• Alkaline phosphatase levels ≤ 2.5 x ULN (≤ 5 x ULN in presence of bone metastasis)
• Absolute neutrophil count of ≥ 1,500/mm³ (≥ 1.5 x 10⁹/L)
• Platelet count ≥ 100,000/mm³ (≥ 100 x10⁹/L)
• Hemoglobin ≥ 9 g/dL
• For women of childbearing potential (WOCBP), a negative serum pregnancy test result at screening and negative urine pregnancy test on Day 1

You may not qualify if:

• Uncontrolled concurrent illness, including ongoing or active infection, uncontrolled hypertension,or any other condition that could raise the subject's safety risk.
• Altered mental status, psychiatric illness, or social situation that could limit compliance with study requirements and/or confound interpretation of study results.
• Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
• Known brain metastasis that has not been treated and stable for at least 4 weeks, or subjects with leptomeningeal disease.
• Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with absorption of oral drugs.
• A history of major surgery within 28 days of first receipt of study drug. Subjects must have recovered fully from any surgery.
• Nursing or pregnant women
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in opinion of investigator, contraindicates use of an investigational drug, or that may render subject at excessively high risk for treatment complications.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (3)

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Study Officials

• Agnes Elekes, M.D.

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 26, 2011
• Study Start: February 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

US (3)