A Phase I Dose Escalation And Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL)


Condition: Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03460977

Sponsor: Pfizer

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Key Inclusion Criteria:

  • Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts: Part 1A (closed to enrollment): Advanced/unresectable or metastatic SCLC, CRPC and FL that is refractory to or intolerable of standard treatment, or for which no curative treatment is available. Note for FL (Parts 1A and 1B) during the dose finding phase of study, follicular lymphoma patients must have exhausted all standard of care therapies. Part 1B (closed to enrollment): FL; patients should have exhausted all curative therapies and have relapsed or refractory disease. Part 1C: Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PWG3) Part 2A:
  • Treatment na├»ve extensive disease SCLC patients;
  • Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have evidence of prostate cancer progression (per PWG3) Part 2B: Castration resistant prostate cancer. Patients should have received abiraterone treatment, may have received up to 1 prior line of chemotherapy, have not received prior enzalutamide, and have evidence of prostate cancer progression (per PWG3) Patients must have radiographic evidence of disease Other

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Adequate organ function

Key Exclusion Criteria:

  • Prior Chemotherapy: Part 1C (CRPC): no more than 2 previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of systemic chemotherapy SCLC: must be chemotherapy naive for SCLC (may have received one cycle of chemotherapy after discussion with the sponsor) Part 2B (CRPC): no more than 1 previous regimen of chemotherapy i
  • Prior irradiation to >25% of the bone marrow.
  • QTcF interval >480 msec at screening.
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC) or platinum compound.
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.

View trial on ClinicalTrials.gov


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