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A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

Inclusion Criteria:

- Pathologically and/or cytologically confirmed advanced malignancy that is refractory
to standard therapy or for which there are no standard treatment options available

- For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives,
whichever is shorter, need to have elapsed since the last dose

- Recovery from adverse effects of prior therapy at time of enrollment to

o ≤ Grade 1 (excluding alopecia)

- Agreement to forego any other chemotherapy, immunotherapy, radiotherapy, or
investigational drug while enrolled on this trial except hormonal therapy for
prostate cancer or radiotherapy for symptomatic bone metastases known to be present
at Screening

- Male or female subjects aged ≥ 18 years

- ECOG performance status ≤ 2

- Adequate organ function

- Life expectancy of ≥ 3 months following trial entry

- For women of childbearing potential, a negative serum pregnancy test result at

- For women of childbearing potential or men whose sexual partners are women of
childbearing potential, agreement to use 2 methods of adequate contraception prior to
trial entry, for the duration of the trial, and for 90 days after the last dose of
trial medication

- Signed and dated IRB-approved informed consent prior to any performance of
protocol-specific screening procedures

Exclusion Criteria:

- Uncontrolled concurrent illness, including but not limited to: ongoing or active
infection; uncontrolled heart, liver, kidney, or endocrine disorder

- Altered mental status, psychiatric illness, or social situation that would limit
compliance with trial requirements and/or obscure trial results

- Immunocompromised state

- Known or evidence of chronic viral hepatitis (hepatitis B or C virus)

- Untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease

- Inability to swallow oral meds or gastrointestinal disorder that might interfere with
absorption of oral drugs

- Major surgery within 28 days of first receipt of trial drug

- Nursing or pregnant women

- ≥ Grade 1 neuropathy with pain or > Grade 2 neuropathy without pain (subjects with
neuropathy caused by a previous regimen that is recovered to ≤ Grade 2 and stable
without pain may be included)

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of OPB-111077

Outcome Description:

AEs, Vital signs,Body weight, ECGs, Laboratory tests, Performance status

Outcome Time Frame:

28 Days

Safety Issue:


Principal Investigator

Edwin Rock, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Otsuka Pharmaceutical Development & Commercialization, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

April 2015

Related Keywords:

  • Solid Tumors
  • Solid tumors



Austin, Texas  78705