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NCT03307148: STAR_PAC
Stromal TARgeting for PAncreatic Cancer (STAR_PAC)
Phase 1 trial testing ATRA in Pancreatic Adenocarcinoma in 29 participants. Completed in 19 March 2019.
19 March 2019
Quick facts
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 15 January 2016 |
| Primary completion | 19 March 2019 |
| Estimated completion | 19 March 2019 |
| Sites | 4 locations across United Kingdom |
Drugs / interventions tested
- ATRA — full drug profile →
- Gemcitabine (gemcitabine) — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
Conditions studied
- Pancreatic Adenocarcinoma — all drugs for Pancreatic Adenocarcinoma →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
18 and older, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pancreatic cancer (PDAC) is the fourth highest cancer killer worldwide and is responsible for 6% of cancer deaths. Around 80% of patients are diagnosed at a late stage when cancer has spread and surgical removal is no longer possible. At present there are no treatments available which will shrink the tumour to enable surgical removal. A main factor in the lack of treatment options for patients is that pancreatic cancer is surrounded by a thick scar tissue called the stroma, which forms a barrier to prevent chemotherapy from entering and shrinking the tumour. Research carried out in laboratories has shown that a derivative of Vitamin A, All Trans Retinoic Acid (ATRA), may have the ability to break down this stroma allowing chemotherapy to reach the cancer. STAR\_PAC will test the combination of ATRA with two chemotherapy drugs; Gemcitabine and Nab-Paclitaxel in patients with locally advanced or metastatic pancreatic cancer. There are two parts to the study; the first will test different doses of the drugs on around 24 patients to find the highest dose patients can take without too many side effects. The second part will test this dose on around 10 patients to find the dose that will produce the desired effect with limited side effects. Patients will take ATRA for up to 6 cycles and chemotherapy until their cancer worsens and will be followed up for 12 months. The study will also explore the ability of a type of scan, DW-MRI, to detect changes in the cancer (optional for patients). Patients can also opt to donate additional tumour samples (biopsies) and normal cell samples (cheek cells and hair samples). Eligible patients will be recruited through NHS Clinics and should have histologically confirmed locally advanced or metastatic pancreatic cancer according to RECIST criteria and must have received no prior treatment for this cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The role of collagen in cancer: from bench to bedside.
Xu S, Xu H, Wang W, Li S, et al · · 2019 · cited 545× · PMID 31521169 · DOI 10.1186/s12967-019-2058-1 -
Pancreatic Cancer Chemoresistance to Gemcitabine.
Amrutkar M, Gladhaug IP. · · 2017 · cited 354× · PMID 29144412 · DOI 10.3390/cancers9110157 -
Therapeutic targeting of "undruggable" MYC.
Llombart V, Mansour MR. · · 2022 · cited 349× · PMID 34942444 · DOI 10.1016/j.ebiom.2021.103756 -
The Extracellular Matrix and Pancreatic Cancer: A Complex Relationship.
Weniger M, Honselmann KC, Liss AS. · · 2018 · cited 208× · PMID 30200666 · DOI 10.3390/cancers10090316 -
The Interplay between Extracellular Matrix Remodeling and Cancer Therapeutics.
Prakash J, Shaked Y. · · 2024 · cited 201× · PMID 39091205 · DOI 10.1158/2159-8290.cd-24-0002 -
Targeting the tumor stroma for cancer therapy.
Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1 -
Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer.
Kocher HM, Basu B, Froeling FEM, Sarker D, et al · · 2020 · cited 166× · PMID 32973176 · DOI 10.1038/s41467-020-18636-w -
The impact of cancer-associated fibroblasts on major hallmarks of pancreatic cancer.
Sun Q, Zhang B, Hu Q, Qin Y, et al · · 2018 · cited 154× · PMID 30429887 · DOI 10.7150/thno.26546
Verify or expand the search:
- PubMed search for NCT03307148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Pancreatic Adenocarcinoma
Currently open trials in the same condition.
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Other Barts & The London NHS Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03307148 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barts & The London NHS Trust
- Last refreshed: 22 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03307148.
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