B7661001 - PF-06647020 in patients with Advanced Solid Tumor
Research type
Research Study
Full title
A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
IRAS ID
231912
Contact name
Ottavio Vitolo
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2014-003296-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The purpose of this research study is to learn about the safety and effectiveness of the study drug, PF-06647020, when given to patients with advanced solid tumour, given alone or in combination with Avelumab (another Study drug), once every 2 weeks.
Earlier in this study, PF-06647020 was given alone every 3 weeks to 112 patients with advanced solid tumours to find the best dose for treating cancer.
This research study has been expanded to learn about the safety and effectiveness of PF-06647020 when given alone, once every 2 weeks to patients with Ovarian Cancer and Non-Small Cell Lung Cancer, and when combined with another study drug called avelumab.The UK participants will only take part in Part 2, the dose expansion portion of the sub-study as described in annex 8 of the protocol, page 142.
During this study Part 2 dose expansion will start to investigate further safety, pharmacokenetic and efficacy of a once every 2 weeks of PF-06647020 in 3 cohorts of patients.
Cohort 1 - Single agent treatment of PF-06647020 in patients with platinum resistant ovarian cancer
Cohort 2 - Single agent treatment of PF-06647020 in patients with recurrent advanced non-small cell lung cancer.
Cohort 3 - PF-06647020 in combination with avelumab in platinum resistant or refractory Ovarian Cancer.Patients will participate in this study on average for 9 months.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0226
Date of REC Opinion
11 May 2018
REC opinion
Further Information Favourable Opinion