Phase IIb Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer (STARPAC2)
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ClinicalTrials.gov Identifier: NCT04241276 |
Recruitment Status :
Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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Sponsor:
Queen Mary University of London
Collaborators:
Medical Research Council
Celgene
Information provided by (Responsible Party):
Queen Mary University of London
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 22, 2020 | ||||||||
First Posted Date ICMJE | January 27, 2020 | ||||||||
Last Update Posted Date | January 27, 2020 | ||||||||
Estimated Study Start Date ICMJE | April 30, 2020 | ||||||||
Estimated Primary Completion Date | February 22, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on progression free survival (PFS). [ Time Frame: Assessed 8 weekly until progression or death ] PFS defined as the time from the date of randomisation to the date of first documented tumour progression or death from any cause, whichever occurs first.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase IIb Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer | ||||||||
Official Title ICMJE | Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer | ||||||||
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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pancreatic Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
170 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 29, 2024 | ||||||||
Estimated Primary Completion Date | February 22, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04241276 | ||||||||
Other Study ID Numbers ICMJE | 274948 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Queen Mary University of London | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Queen Mary University of London | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Queen Mary University of London | ||||||||
Verification Date | January 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |