Last updated on February 2020

PF-06821497 Treatment Of Relapsed/Refractory SCLC Castration Resistant Prostate Cancer and Follicular Lymphoma


Brief description of study

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).

Detailed Study Description

This is an open label, multi center, Phase 1 dose escalation study of PF 06821497 administered orally as a single agent BID to patients with SCLC, CRPC, DLBCL and FL (Part 1A). For Part 1B (dose escalation monotherapy), PF 06821497 will be administered as monotherapy in patients with FL. For Part 2A (dose escalation combination therapy), PF 06821497 will be administered in combination with SOC in patients with SCLC and CRPC. For Part 2B (dose expansion), PF 06821497 will be administered in combination with SOC in patients with SCLC and CRPC, and as monotherapy in patients with FL.

Part 1A (escalation monotherapy) will assess PF 06821497 administered as a single agent twice daily in a continuous regimen to patients with advanced tumors (SCLC CRPC, DLBCL and FL). A modified toxicity probability interval (mTPI) dose finding design will be applied in 2 4 patient cohorts. The starting dose of PF 06821497 will be 75 mg BID (DL1). Once the safety and adequate target modulation has been established Parts 1B and 2A of the trial will be initiated. Additional dose levels may be investigated, if adequate target inhibition has not been achieved at DL3.

Part 1B [escalation recommended Phase 2 dose (RP2D) finding - monotherapy] will determine the maximum tolerated dose (MTD) of monotherapy in FL (MTD1).

Part 2A (escalation RP2D finding -combination) will determine the MTD of the combination with SOC in patients with SCLC (cisplatin or carboplatin with etoposide, MTD2, MTD3) and CRPC (MTD4). Part 2B (dose expansion) will assess the efficacy of PF 06821497 at the RP2D identified from the Part 2A, in combination with SOC in patients with SCLC (n=16 to 30 for the 2 combination regimens), and CRPC (n=8 to 20) in addition to as a single agent twice daily in patients with FL (n=8 to 20).

Clinical Study Identifier: NCT03460977

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