Trial ID:NCT03460977
Protocol #:18-159
Condition(s):Castration Resistant Prostate Cancer (CRPC), Follicular Lymphoma (FL), Small Cell Lung Cancer (SCLC)
Phase:I
Principal Investigator:Choudhury, Atish
Site Investigator(s):Lee, Richard, J.
Site Research Nurse(s):Aspinwall, Sheridan,
Baylies, Rosemarie,
Beardslee, Brian,
Bretta, Katherine, v.
Caramella, Anne,
Carey, Margaret, M.
DeGonge, Danielle,
Gillen Mckay, Christine, A.
Harran, John,
Hart, Kayla,
Hassinger, Faith,
Hedglin, Jennifer,
Hewes, Julia,
Leisner, Claire,
Mackoul, Anna,
McCarthy, Elizabeth, Ann
Mingrino, Sage,
O’Neill, Kailene,
Patchel, Rachel, Alexandra
Powers, Allison,
Prisby, Judith,
QUINN, NICHOLAS,
Rang, Bethany,
Rowan, Jennifer, M.
Trial Description:
A Phase 1 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).
Eligibility Requirements:
Key Histological or cytological diagnosis of advanced / metastatic solid tumor with the
following tumor types in individual study parts:
Part 1A (closed to enrollment):
Part 1B (closed to enrollment):
Part 1C:
• Castration resistant prostate cancer. Patients should have received either abiraterone
and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)
Part 2A:
• 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 PCWG3)
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 PCWG3)
- 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 Part 2B (CRPC): no more
than 1 previous regimen of chemotherapy
- 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)
- 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.
Protocol #: 18-159