WaKING: Wnt and checKpoint INhibition in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT04166721|
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Esophageal Cancer Metastatic Gastric Cancer||Drug: Atezolizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Non-randomised Trial Assessing the Efficacy of DKN-01 Plus Atezolizumab in Patients With Advanced Mismatch Repair Proficient Oesophagogastric Cancer|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||September 11, 2022|
|Estimated Study Completion Date :||September 11, 2025|
Experimental: DKN-01 and atezolizumab
DKN-01 is an intravenous medication which will be given at a variable dose during the Phase IIA safety run in phase of the trial (150mg, 300mg or 600mg IV q14d).
During the Phase IIB efficacy phase of the trial patients will be treated with DKN-01 at the safe and tolerated combination dose identified during the Phase IIA safety run in phase.
Atezolizumab is a monoclonal antibody which is given via an intravenous infusion at a dose of 840mg on the first day of a two week cycle. (Day 1 q 14d) from cycle 2 onwards.
In the first cycle of treatment, patients will be treated with only DKN-01, and following this they will be treated with both DKN-01 and atezolizumab
Other Name: DKN-01
- Safety run-in phase: To recommend a safe and tolerable dose of combination DKN-01 and atezolizumab for use in the main (Phase IIB efficacy) phase of this trial. [ Time Frame: The DLT period is 28 days from the start of the combination of DKN-01 and atezolizumab for any given patient (i.e. from C2 D1) ]Progression through dose levels will be determined by the occurence of dose limiting toxicities in the study population
- Main phase IIB (efficacy) phase: Best objective response rate (ORR) using RECIST 1.1 criteria [ Time Frame: 24 months ]ORR will be defined in the mITT population as the proportion of patients who have achieved CR or PR (as assessed according to RECIST 1.1 criteria) as their best overall response during treatment. The rate will be presented as a proportion with an exact 95% confidence interval.
- The safety of DKN-01 plus atezolizumab will be assessed in the Safety Population (SFP) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: Up to 135 days after the last dose ]
- Progression free survival (PFS) according to RECIST 1.1 [ Time Frame: Up to 24 months ]PFS will be estimated in the mITT population using the Kaplan Meier method and presenting median survival with 95% confidence intervals. 6 month and 1 year PFS will also be reported. PFS will be defined as time from first drug administration (C1D1) to clinical/radiological progression or death from any cause.
- Overall survival [ Time Frame: Up to 24 months ]OS will be estimated in the mITT population using the Kaplan Meier method and presenting median survival with 95% confidence intervals. 6 month and 1 year OS will also be reported. PFS will be defined as time from first drug administration (C1D1) to clinical/radiological progression or death from any cause and OS will be defined time from first drug administration (C1D1) to date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166721
|The Royal Marsden NHS Foundation Trust||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Richard Crux 02086426011 ext 3807 firstname.lastname@example.org|
|Sub-Investigator: Fiona Turkes|
|Principal Investigator: David Cunningham|