Gynecologic

General Information



A Phase I, dose escalation, safety and Pharmacokinetic study of PF-06647020 in adult patients with advanced solid tumors (Pfizer B7661001)


Adult


NCT02222922


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.


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


Catherine D’Reaux, RN, BSN, OCN


703-208-6630


catherine.dreaux@inova.org

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT02222922