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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)

Enrolling

Trial ID:NCT03460977

View complete trial on ClinicalTrials.gov

Protocol #:18-159

877-DF-TRIAL (877-338-7425)

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

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)