Dose Escalation Study of INK1117 in Subjects With Advanced Cancer

Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01449370 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-209

 

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of INK1117 when administered orally in subjects with advanced solid malignancies.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jose Baselga M.D., Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy. - Age ≥ 18 years, including males and females; - ECOG performance status (PS) 0-1; - Adequate organ function; - Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration; - Ability to swallow oral medications; - Ability to understand and willingness to sign informed consent prior to initiation of any study procedures; - For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration; Exclusion Criteria: - Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression; - Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug; - Have received a hematopoietic growth factor or systemic corticosteroid within one week prior to the first administration of study drug; - Clinically significant cardiac disease; - Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug; - Malabsorption ; - Diabetes mellitus; - Pregnancy (positive serum or urine pregnancy test) or breast feeding;
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