A Study of Ibrutinib Combination Therapy in Advanced Tumour Patients
Research type
Research Study
Full title
A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors
IRAS ID
199044
Contact name
Ian Chau
Contact email
Sponsor organisation
Pharmacyclics LLC
Eudract number
2015-003656-40
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 1 months, 29 days
Research summary
Summary of Research
Ibrutinib is approved by FDA and EMEA for certain cancers, however not for treatment of kidney, bladder, stomach, or colon cancer and so is considered experimental. In this clinical trial, total 261 patients who have one of the following four cancers will be treated using Ibrutinib in combination with one approved treatment for each cancer: Kidney cancer (Renal cell carcinoma) with daily Everolimus tablets, Bladder cancer (Advanced urothelial carcinoma) with weekly Paclitaxel infusion, Stomach cancer (Advanced gastric adenocarcinoma) with 3 weekly Docetaxel infusion, and Colon cancer (Metastatic colorectal adenocarcinoma) with weekly Cetuximab infusion.
This study has two phases, phase 1 and phase 2. Upon agreement to be in the study and after screening tests, participants will undergo 21day-cycle of treatments. During the phase 1, participants will take ibrutinib daily in combination with fixed doses of the established cancer treatments to decide which dose of ibrutinib should be used for each cancer type in the phase 2. Starting from 560mg daily dose, ibrutinib will be reduced to 420mg if it causes a toxicity affecting Dose in certain number of a participant group, or raised to 840mg if it is safe. In the phase 2, we will find out what effects ibrutinib in combination with the established treatments will have on kidney, bladder, stomach, or colon cancer.
Treatment for all participants will continue until their disease progresses, they have unacceptable toxicities, they choose to stop treatment, or if they become pregnant. After the treatment is stopped for any reason, we will do end of treatment tests on participants, and will follow up the participants every 6 weeks until they start another treatment or their disease progresses. During participating, their cancer will be monitored using various tests including CT and/or MRI scans, Tumour tissue analysis, blood and urine samples, and optional tumour biopsy.
Summary of Results
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REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0685
Date of REC Opinion
18 May 2016
REC opinion
Further Information Favourable Opinion