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).
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. Japan and China monotherapy cohorts will evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese and Chinese patients. 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.
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) 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) China cohort
Castration resistant prostate cancer that is intolerant/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 who refused SOC may be eligible. 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, apalutamide or darolutamide 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 , Japan cohort and China cohort (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 (>150/90 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.
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There are 76 Locations for this study
Tucson Arizona, 85715, United States
Tucson Arizona, 85719, United States
Tucson Arizona, 85719, United States
Tucson Arizona, 85724, United States
Tucson Arizona, 85741, United States
Anaheim California, 92801, United States
Duarte California, 91010, United States
Duarte California, 91010, United States
Norwalk Connecticut, 06856, United States
Peoria Illinois, 61615, United States
Fairway Kansas, 66205, United States
Fairway Kansas, 66205, United States
Kansas City Kansas, 66160, United States
Kansas City Kansas, 66160, United States
Overland Park Kansas, 66211, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Omaha Nebraska, 68130, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Myrtle Beach South Carolina, 29572, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Irving Texas, 75063, United States
Irving Texas, 75063, United States
Irving Texas, 75063, United States
San Antonio Texas, 78240, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98109, United States
Haskovo , 6300, Bulgaria
Plovdiv , 4004, Bulgaria
Ruse , 7002, Bulgaria
Vratsa , 3000, Bulgaria
Guangzhou Guangdong, 51012, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Cheng Du Sichuan, 61004, China
Cheng Du Sichuan, 61004, China
Wenzhou Zhejiang, 32500, China
Kashiwa Chiba, 277-8, Japan
Goyang-si Kyǒnggi-do, 10408, Korea, Republic of
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 03722, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 05505, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06273, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 07985, Korea, Republic of
Daegu Taegu-kwangyǒkshi, 41404, Korea, Republic of
Daejeon Taejǒn-kwangyǒkshi, 35015, Korea, Republic of
Koszalin , 75-58, Poland
Koszalin , 75-90, Poland
Rzeszow , 35-32, Poland
Rzeszow , 35-32, Poland
Warszawa , 01-74, Poland
Warszawa , 02-78, Poland
Pushkin Saint - Petersburg, 19660, Russian Federation
Pushkin Saint Petersburg, 19660, Russian Federation
Pushkin Saint-petersburg, 19660, Russian Federation
Moscow , 11718, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 12930, Russian Federation
Omsk , 64401, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint Petersburg , 19825, Russian Federation
Saint-Petersburg , 19527, Russian Federation
Saint-Petersburg , 19527, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Yaroslavl , 15005, Russian Federation
L'Hospitalet de Llobregat Barecelona, 08908, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Barcelona , 08023, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Castellon , 12002, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
València , 46026, Spain
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