AZD6094 in patients with papillary renal cell carcinoma
Research type
Research Study
Full title
A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients with Papillary Renal Cell Carcinoma (PRCC)
IRAS ID
158667
Contact name
Hendrik-Tobias Arkenau
Contact email
Sponsor organisation
AstraZeneca UK Limited
Eudract number
2014-001858-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This is an open-label, single-arm, multicentre, global, Phase II, 2-staged study designed for patients with locally advanced or metastatic Papillary Renal Cell Carcinoma (PRCC). An independent central pathology review will be utilised to confirm the PRCC histology of all patients. Local confirmation of PRCC will be allowed for study entry.
All patients entering the study will take AZD6094 600 mg by mouth (PO) once daily (QD). For the purposes of planning, a 3-week treatment period will be called a Cycle. Treatment will be given continuously. Patients may continue to receive AZD6094 beyond defined progression as long as they are continuing to show clinical benefit, as judged by the Investigator. Patients will undergo restaging for anti-tumour activity of AZD6094 every 6 weeks, for the first 12 months and every 12 weeks thereafter until objective disease progression.
Patients with easily accessible tumours should be asked to consent to the paired biopsy sampling portion of this study. Fresh biopsy pairs (pre-treatment and on-treatment [Cycle 1 Day 8]) will be collected to evaluate the pharmacodynamic effect of AZD6094.
This study will employ a 2-stage design. Stage 1 will include approximately 20 patients. If =6 tumour responses are observed in the first 20 evaluable patients, a further cohort of approximately 55 patients will be accrued in Stage 2 bringing the total number of patients to approximately 75. If =5 tumour responses are observed in the first 20 evaluable patients, progression to Stage 2 of the study in a patient population as defined in Stage 1 of the study will not take place. Further recruitment in Stage 2 of the protocol in a defined subset of patients may be considered if supported by molecular analysis of the first 20 evaluable patients.
REC name
London - Central Research Ethics Committee
REC reference
14/LO/2041
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion