NCT04241276

A Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer

Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 Treatment may be discontinued earlier due to unacceptable toxicities or death or because the patient requests to be withdrawn from study treatment.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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	ATRA	45 mg/m2 orally (in two divided doses) from days 1 to 15 of each cycle
DRUG	Gemcitabine	1000mg/m2 IV on days 1, 8 and 15 of a 28 day cycle
DRUG	nab-paclitaxel	125mg/m2 IV on days 1, 8 and 15 of a 28 day cycle

Timeline

• Start date: 2020-04-30
• Primary completion: 2028-06-29
• Completion: 2029-02-28
• First posted: 2020-01-27
• Last updated: 2026-01-07

Locations

1 site across 1 country: United Kingdom