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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)

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Not Recruiting

June. 27, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts:

Japan cohort
*Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)

Other inclusion criteria:
*Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
*Adequate organ function

*Prior Chemotherapy: no more than 2 previous regimens of chemotherapy
*Prior irradiation to >25% of the bone marrow.
*QTcF interval >480 msec at screening.
*Hypertension that cannot be controlled by medications (>150/90 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.

Male

Castration Resistant Prostate Cancer (CRPC)

Drug: PF-06821497
Oral continuous
Other Name: EZH2i

1.Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) [ Time Frame: Baseline up to 90 days ]
First cycle DLTs will be utilized to determine the MTD

2.Overall safety profile including adverse events [ Time Frame: Baseline up to approximately 2 years ]
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [4.03])

3.Preliminary efficacy determination as evaluated by disease specific response criteria [ Time Frame: Through study completion, approximately 2 years past last patient first visit. ]
Objective response using Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC).

4.Overall safety profile including laboratory abnormalities [ Time Frame: Baseline up to approximately 2 years ]
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version [4.03]), and timing.

5.Overall safety profile including vital signs [ Time Frame: Baseline up to approximately 2 years ]
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.

1.Evaluate time to event anti-tumor activity of PF-06821497 including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type. [ Time Frame: Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years. ]
Time to event endpoints based on Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC)

2.Evaluate overall survival [ Time Frame: Baseline up to approximately 2 years ]
Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.

3.Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Single dose and multiple dose PK will be calculated as data permits

4.Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Single dose and multiple dose PK will be calculated as data permits

5.Pharmacokinetic Parameters: Area Under the Curve (AUC) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Single dose and multiple dose PK will be calculated as data permits

6.Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Single dose and multiple dose PK will be calculated as data permits

7.Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Single dose and multiple dose PK will be calculated as data permits

8.Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2) [ Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit ]
Singe dose and multiple dose PK will be calculated as data permits

+81-3-3542-2511

April. 12, 2023

No

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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