Lung Cancer Clinical Trial

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

Summary

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).

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Full Description

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of PF-06821497 administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be administered as monotherapy in patients with FL in Part 1B dose escalation and to patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1 ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single agent PF-06821497 in patients with mCRPC. Part 2A (escalation RP2D finding for combination) will determine the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.

View Eligibility Criteria

Eligibility Criteria

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):

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

185

Study ID:

NCT03460977

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 44 Locations for this study

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Urological Associates of Southern Arizona, P.C .
Tucson Arizona, 85715, United States
Banner-University Medical Center Tucson
Tucson Arizona, 85719, United States
The University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Urological Associates of Southern Arizona, PC
Tucson Arizona, 85741, United States
Pacific Cancer Medical Center INC
Anaheim California, 92801, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte California, 91010, United States
Norwalk Hospital
Norwalk Connecticut, 06856, United States
Illinois CancerCare, P.C.
Peoria Illinois, 61615, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway Kansas, 66205, United States
The University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
The University of Kansas Hospital
Kansas City Kansas, 66160, United States
The University of Kansas Medical Center Medical Office Building
Kansas City Kansas, 66160, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park Kansas, 66211, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville Kentucky, 40202, United States
Norton Cancer Institute Pharmacy
Louisville Kentucky, 40202, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville Kentucky, 40202, United States
Norton Hospital
Louisville Kentucky, 40202, United States
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
OU Medical Center Presbyterian Tower
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach South Carolina, 29572, United States
Tennessee Oncolgy, PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States
Texas Oncology -Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
US Oncology Investigational Product Center (IPC)
Irving Texas, 75063, United States
US Oncology Investigational Product Center (IPC)
Irving Texas, 75063, United States
US Oncology Investigational Products Center
Irving Texas, 75063, United States
NEXT Oncology
San Antonio Texas, 78240, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
LLC "Neyro-klinika"
Moscow , 11718, Russian Federation
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
Moscow , 12528, Russian Federation
SBHI of Moscow City Clinical Hospital
Moscow , 12930, Russian Federation
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
Omsk , 64401, Russian Federation
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
Saint Petersburg , 19734, Russian Federation
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg , 19825, Russian Federation
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
Saint-Petersburg , 19527, Russian Federation
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Saint-Petersburg , 19527, Russian Federation
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
Saint-Petersburg , 19775, Russian Federation
State Budgetary Healthcare Institution of the Yaroslavl Region
Yaroslavl , 15005, Russian Federation
Institut Català d´Oncología (ICO)-H. Durán i Reynals
L'Hospitalet de Llobregat Barecelona, 08908, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon , 12002, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
H.U. Fundación Jiménez Díaz
Madrid , 28040, Spain
Hospital Universitario 12 De Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

185

Study ID:

NCT03460977

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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