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.


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

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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