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Gynecologic
General Information
Study Name:
A Phase I, dose escalation, safety and Pharmacokinetic study of PF-06647020 in adult patients with advanced solid tumors (Pfizer B7661001)
Age Group:
Adult
Protocol Number:
NCT02222922
Background Information:
This phase I trial is designed to assess safety and tolerability at increasing dose levels of PF-06647020 administered intravenously on an every 21-day dosing schedule to patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.
Offered at:
Inova Schar Cancer Institute
3289 Woodburn Rd., #245
Annandale, VA 22003
Eligibility Information
Participant has/had histological or cytological diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available
Adequate liver, bone marrow, and renal function
Additional eligibility in protocol
Ineligibility Information
Patients with known symptomatic brain metastases requiring steroids
Previous high dose chemotherapy requiring stem cell rescue
Presence of Grade ≥2 peripheral neuropathy
OVCA patients with any of the following:
Non-epithelial, including malignant mixed Müllerian tumors
Ovarian tumors with low malignant potential (ie, borderline tumors)
Previous treatment with > three (3) anti-cancer regimens
Any prior radiotherapy to the pelvis or abdomen
Patients with CA-125-only disease
Previous exposure to murine CA-125 antibody
Unresolved bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
Prior treatment with a compound of the same mechanism
Currently receiving active treatment in another clinical study
Additional exclusions in protocol
Contact Information
Contact Name:
Catherine D’Reaux, RN, BSN, OCN
Contact Phone:
703-208-6630
Contact Email:
catherine.dreaux@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/NCT02222922