A Two Part, Multicenter, Open-label Study of TEN-010 Given Subcutaneously

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01987362 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-503


TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity of TEN-010 in patients who are refractory or intolerant to standard/approved therapies. This first-in-human study of TEN-010 will be conducted in two parts: dose escalation and dose expansion. For dose escalation (Part A), a standard "3+3" design will be used in which successive cohorts of three or more patients with advanced solid tumor malignancies will be treated at escalating doses until a maximum tolerated dose (MTD) is identified. For the dose expansion part of the study (Part B), a subset of patients with advanced solid malignancies will be treated with TEN-010 at the MTD (or the highest dose tested if the MTD is not defined) to further characterize safety and biological effect. In addition, up to 10 patients with nuclear protein in testis (NUT) midline carcinoma (NMC) will be permitted to enroll in a substudy of the protocol.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

INCLUSION CRITERIA General - Patients with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging - Ambulatory patients >= 18 years of age - ECOG performance status of 0 or 1 (or 2 upon approval by the medical monitor) - Life expectancy of >= 3 months - Disease-free of active second/secondary or prior malignancies >= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast - Adequate hematological, renal, hepatic and coagulation laboratory test results. - Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug. - Available for the duration of the study and willing to follow study procedures - Provide written informed consent Advanced Solid Malignancies - Patients with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy - Patients must be refractory or intolerant to standard therapy NUT-midline carcinoma - Patients with histologically confirmed newly diagnosed or relapsed/refractory NUT-midline carcinoma (NMC) with progressive disease requiring therapy - Diagnosis of one of the following is required: 1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or; 2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH). EXCLUSION CRITERIA - Patients with hematologic malignancies - New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia - Have QTcF > 470 msec (female) or > 450 (male), or history of congenital long QT syndrome - Active, uncontrolled bacterial, viral, or fungal infections - Known clinically important respiratory impairment - Positive for HIV, hepatitis B surface antigen, or hepatitis C antibodies - History of major organ transplant - History of an autologous or allogeneic bone marrow transplant - Symptomatic central nervous system malignancy or metastasis - Pregnant or nursing - Treatment with surgery or chemotherapy within 28 days prior to study entry - Prior treatment with small molecule (BET) family inhibitor - Radiation for symptomatic lesions within 14 days of study enrollment - Other exclusions apply
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