A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01004224 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-446

 

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety. The study will also investigate preliminary anti-tumor activity of the compound in treated patients.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Lecia Sequist, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists - Adequate bone marrow function - Adequate hepatic and renal function - Adequate cardiovascular function - Contraception. - For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing. - For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period Exclusion Criteria: - Patients with primary CNS tumor or CNS tumor involvement - Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis - History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification - Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination. - History or current evidence of cardiac arrhythmia and/or conduction abnormality - Women who are pregnant or nursing. Other protocol-defined inclusion/exclusion criteria may apply
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