Dose Escalation Study of INK128 in Subjects With Advanced Cancer

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01058707 (View complete trial on
DFCI Protocol ID: 10-430


The purpose of this study is to determine the safety, tolerability, dose limiting toxicities and pharmacokinetics of INK128 in subjects with advanced cancer.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Eunice Kwak, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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; - ECOG performance status 0-1; - Ability to swallow oral medications; - Life expectancy of ≥6 months; - For women of child-bearing potential, negative serum or urine 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 30 days following the last study drug administration; - 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 understand and willingness to sign informed consent form prior to initiation of any study procedures. Exclusion Criteria: - Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug; - Known impaired cardiac function or clinically significant cardiac disease; - Diabetes mellitus; - HIV infection; - Failed to recover from the reversible effects of prior anticancer therapies; - Pregnancy (positive serum or urine pregnancy test) or breast feeding; - Malabsorption due to prior gastrointestinal (GI) surgery, GI disease; - Other clinically significant co-morbidities.
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