Pancreatic CancerPhase 2STARPAC2NCT04241276
A Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer
A Phase 2 study testing ATRA, Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ATRA, Gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2020to 28 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Written informed consent prior to admission to this study
- Age ≥16 years. No upper age limit.
- ECOG performance status 0 or 1
- Histologically proven pancreatic ductal adenocarcinoma (PDAC) as part of the Precision-Panc Master Protocol, or for patients who have gone exploratory laparotomy and found to have locally, unresectable advanced disease.
- Locally advanced disease which is measurable according to the Response Evaluation Criteria in Solid Tumours (RECIST v1.1).
Show all 19Show fewer
- CT chest abdomen and pelvis as well as PET-CT within 28 days of day 1 of treatment (MRI Liver only if indeterminate liver lesions) to confirm absence of metastatic disease.
- Received no prior systemic therapy for pancreatic cancer.
- Adequate haematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- Absolute Neutrophil Count ≥ 1.5 x 109/l (without granulocyte colony-stimulating factor support within 2 weeks prior to the first study treatment)
- Platelet count ≥ 100 x 109/l (without transfusion within 2 weeks prior to the first study treatment)
- Haemoglobin ≥ 10 g/dl (transfusion permitted to establish target haemoglobin levels prior to the first study treatment)
- Calculated creatinine clearance (e.g. Cockcroft-Gault) ≥ 50 ml/min
- Bilirubin level ≤ 1.5 ULN (patients with known Gilbert disease who have bilirubin levels ≤ 3 x ULN may be enrolled). Patients must be able to undergo biliary stenting if required before or, if required, during the trial
- AST or ALT <2.5 x ULN
- Alkaline phosphatase (ALP) <2.5 x ULN
- INR and aPTT ≤1.5 x ULN; this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- Female patients of child-bearing potential are eligible, provided they have a negative serum pregnancy test within 7 days prior to the first dose of study treatment, preferably as close to the first dose as possible. All patients with reproductive potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 1 month after discontinuation of ATRA and / or gemcitabine/nab-paclitaxel (whichever is the latest) and for 6 months after discontinuation for male patients. Acceptable methods of contraception include IUD, oral contraceptive, sub-dermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary). Micro-dosed progesterone preparations ("mini-pill") are an inadequate method of contraception during treatment with ATRA. If patients are taking this pill they should be instructed to stop and another form of contraceptive should be prescribed instead.
- Able to follow protocol requirements as assessed by the Principal Investigator.
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Patient has known distant metastases.
- Patient has experienced a significant reduction in performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, such that the ECOG PS is ≥ 2 as per the Investigator's assessment.
- Patients with pre-existing sensory neuropathy >grade 1
- History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for ≥2 years
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Show all 19Show fewer
- Patient has known active, uncontrolled HIV, or active, uncontrolled hepatitis B or C infection. Patients with undetectable viral load are eligible.
- Patient has undergone major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- Patient has a history of allergy (including soya bean or peanut allergies) or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the products or comparator SmPC or Prescribing Information.
- History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).
- Patient with a history of interstitial lung disease, history of slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
- Patient with high cardiovascular risk , including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
- History of Peripheral Artery Disease (e.g., claudication, Leo-Buerger's disease).
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug at least ≤30 days prior to study entry depending on the half-life of the investigational drug and/or guidance issued by the IMP manufacturer.
- Patient is taking any prohibited concurrent medication, including vitamin A supplements, and is unwilling to stop use prior to and during the trial.
- Patient is pregnant, planning to become pregnant or breast feeding.
- Patient has received a live vaccine within four weeks prior to receiving their first dose of study treatment.
- Patient is unwilling or unable to comply with study procedures, as assessed by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer
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.
Read the 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
- Being tested
- ATRA, Gemcitabine, nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATRADrug
Also called Tretinoin, Vesanoid
45 mg/m2 orally (in two divided doses) from days 1 to 15 of each cycle
GemcitabineDrug
1000mg/m2 IV on days 1, 8 and 15 of a 28 day cycle
nab-paclitaxelDrug
Also called Abraxane
125mg/m2 IV on days 1, 8 and 15 of a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + nab-paclitaxel | Active comparator | Patients will receive Gemcitabine and nab-Paclitaxel in 28 day cycles until disease progression. Receives: Drug: Gemcitabine; Drug: nab-paclitaxel |
| Gemcitabine + nab-paclitaxel + ATRA | Experimental | Patients will receive ATRA, Gemcitabine and nab-Paclitaxel in 28 day cycles. ATRA will be administered for 6 cycles whereas Gemcitabine/nab-Paclitaxel will be administered until disease progression. Receives: Drug: ATRA; Drug: Gemcitabine; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on progression free survival (PFS).
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.
Measured: Assessed 8 weekly until progression or death or end of trial, whichever comes first
Secondary outcomes (6)
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on objective response rate (ORR).
ORR defined as the number of patients with an objective response (OR) divided by the number of patients analysed. OR is defined as the number of patients with at least one confirmed response of complete response (CR) or partial response (PR). OR will be calculated in patients with measurable disease at baseline.
Measured: Assessed 8 weekly until progression or death or end of trial, whichever comes first
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on overall survival (OS).
OS is defined as the time from the date of randomisation to death from any cause.
Measured: Assessed 8 weekly until progression or death and then 3 monthly for at least 12 months after the last safety visit
To assess the safety and tolerability of ATRA when given in combination with gemcitabine and nab-paclitaxel over the first 6 cycles.
The worst recorded toxicity grade for each patient on the NCI-CTCAE toxicity scale (version 5.0) over the first 6 cycles of treatment
Measured: 6 cycles (1 cycle = 28 days)
To assess the surgical resection rate of ATRA when given in combination with gemcitabine and nab-paclitaxel.
Surgical resection rate defined as patients undergoing complete resection of known pancreatic primary and associated lymph nodes at any point after enrolment, in each arm.
Measured: From consent to at least 12 months after the last safety visit, but further if required as per physician decision - through study completion
To assess the resection margin negative (R0) surgical resection rate of ATRA when given in combination with gemcitabine and nab-paclitaxel.
R0 surgical resection rate defined as histologically confirmed complete resection of known pancreatic primary from those resected.
Measured: From consent to at least 12 months after the last safety visit, but further if required as per physician decision - through study completion
To assess quality of life (QOL) of patients receiving ATRA in combination with Gemcitabine and Nab-Paclitaxel: EQ-5D-5L
QoL scores for the five dimensions of the EQ-5D-5L (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) will be used to calculate weighted health status scores.
Measured: Assessed at the beginning of each cycle until progression (1 cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start30 Apr 2020
- Primary completion29 Jun 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Celgene
- Responsible party
- Sponsor
- Investigators
- Hemant Kocher, Professor, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241276
- Sponsor's protocol ID
- 274948
- Acronym
- STARPAC2
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2020
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocher HM; BCI-STARPAC2 team; BPTB team; Precision-Panc team; Sasieni P, Corrie P, McNamara MG, Sarker D, Froeling FEM, Christie A, Gillmore R, Khan K, Propper D. Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2. BMC Cancer. 2025 Jan 20;25(1):106. doi: 10.1186/s12885-024-13333-z.
PubMed 39833722
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04241276
- Acronym / sponsor ID
- STARPAC2 / 274948
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Celgene
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 29 Jun 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + nab-paclitaxel | Active comparator | Drug: Gemcitabine, Drug: nab-paclitaxelPatients will receive Gemcitabine and nab-Paclitaxel in 28 day cycles until disease progression. |
| Gemcitabine + nab-paclitaxel + ATRA | Experimental | Drug: ATRA, Drug: Gemcitabine, Drug: nab-paclitaxelPatients will receive ATRA, Gemcitabine and nab-Paclitaxel in 28 day cycles. ATRA will be administered for 6 cycles whereas Gemcitabine/nab-Paclitaxel will be administered until disease progression. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Written informed consent prior to admission to this study
- Age ≥16 years. No upper age limit.
- ECOG performance status 0 or 1
- Histologically proven pancreatic ductal adenocarcinoma (PDAC) as part of the Precision-Panc Master Protocol, or for patients who have gone exploratory laparotomy and found to have locally, unresectable advanced disease.
Key exclusion criteria (19 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Patient has known distant metastases.
- Patient has experienced a significant reduction in performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, such that the ECOG PS is ≥ 2 as per the Investigator's assessment.
- Patients with pre-existing sensory neuropathy >grade 1
- History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for ≥2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATRAAlso: Tretinoin, Vesanoid45 mg/m2 orally (in two divided doses) from days 1 to 15 of each cycle | Drug | Gemcitabine + nab-paclitaxel + ATRA |
| Gemcitabine1000mg/m2 IV on days 1, 8 and 15 of a 28 day cycle | Drug | Gemcitabine + nab-paclitaxel, Gemcitabine + nab-paclitaxel + ATRA |
| nab-paclitaxelAlso: Abraxane125mg/m2 IV on days 1, 8 and 15 of a 28 day cycle | Drug | Gemcitabine + nab-paclitaxel, Gemcitabine + nab-paclitaxel + ATRA |
Primary outcome
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 or end of trial, whichever comes first
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.
6 secondary outcomes
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on objective response rate (ORR).
Time frame: Assessed 8 weekly until progression or death or end of trial, whichever comes first
To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on overall survival (OS).
Time frame: Assessed 8 weekly until progression or death and then 3 monthly for at least 12 months after the last safety visit
To assess the safety and tolerability of ATRA when given in combination with gemcitabine and nab-paclitaxel over the first 6 cycles.
Time frame: 6 cycles (1 cycle = 28 days)
To assess the surgical resection rate of ATRA when given in combination with gemcitabine and nab-paclitaxel.
Time frame: From consent to at least 12 months after the last safety visit, but further if required as per physician decision - through study completion
To assess the resection margin negative (R0) surgical resection rate of ATRA when given in combination with gemcitabine and nab-paclitaxel.
Time frame: From consent to at least 12 months after the last safety visit, but further if required as per physician decision - through study completion
To assess quality of life (QOL) of patients receiving ATRA in combination with Gemcitabine and Nab-Paclitaxel: EQ-5D-5L
Time frame: Assessed at the beginning of each cycle until progression (1 cycle = 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 39833722Kocher HM; BCI-STARPAC2 team; BPTB team; Precision-Panc team; Sasieni P, Corrie P, McNamara MG, Sarker D, Froeling FEM, Christie A, Gillmore R, Khan K, Propper D. Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2. BMC Cancer. 2025 Jan 20;25(1):106. doi: 10.1186/s12885-024-13333-z.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemant Kocher, Professor study chair
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATRA, Gemcitabine and nab-paclitaxel in people with Pancreatic Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 or end of trial, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.