Spots Global Cancer Trial Database for Phase IIb Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer
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Trial Identification
Brief Title: Phase IIb Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer
Official Title: Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer
Study ID: NCT04241276
Conditions
Study Description
Brief Summary: This is an open-label, multi-centre, randomised, stratified, phase IIb clinical trial of ATRA administered in combination with gemcitabine and nab-paclitaxel in patients with laPDAC.
Detailed Description: Patients will be randomised to receive gemcitabine + nab-paclitaxel or gemcitabine + nab-paclitaxel + ATRA. Treatment will be administered in 28 day cycles. ATRA will be administered for 6 cycles whereas gemcitabine/nab-paclitaxel will be administered until disease progression. Treatment may be discontinued earlier due to unacceptable toxicities or death or because the patient requests to be withdrawn from study treatment. If treatment with gemcitabine/nab-paclitaxel is stopped prior to the patient completing 6 cycles of treatment with ATRA (if allocated), the patient may continue on treatment with ATRA alone until the 6 cycles are completed, at the discretion of the treating physician.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Hemant Kocher, Professor
Affiliation: Queen Mary University of London
Role: STUDY_CHAIR
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