A First in Man Trial for Patients With Cancer

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01711034 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-271


The purpose of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.


Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Cote Gregory, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute
Daniel Cho, MD, Beth Israel Deaconess Medical Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

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 Screening - 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)
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