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
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
linda_pointon@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