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NCT01585805
Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Phase 2 trial testing Biopsy in Locally Advanced Pancreatic Adenocarcinoma in 88 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2024
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 15 May 2012 |
| Primary completion | 31 December 2024 |
| Estimated completion | 6 March 2026 |
| Sites | 12 locations across Canada, United States, Israel |
Drugs / interventions tested
- Biopsy
- Biospecimen Collection — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- Computed Tomography
- Gemcitabine (gemcitabine) — full drug profile →
- Gemcitabine Hydrochloride — full drug profile →
- Magnetic Resonance Imaging
- Veliparib
Conditions studied
- Locally Advanced Pancreatic Adenocarcinoma — all drugs for Locally Advanced Pancreatic Adenocarcinoma →
- Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →
- Stage III Pancreatic Cancer AJCC v8 — all drugs for Stage III Pancreatic Cancer AJCC v8 →
- Stage IV Pancreatic Cancer AJCC v8 — all drugs for Stage IV Pancreatic Cancer AJCC v8 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Locally Advanced Pancreatic Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase II trial studies how well veliparib together with gemcitabine hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread from the primary site (place where it started) to other places in the body (metastatic). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving veliparib together with gemcitabine hydrochloride and cisplatin is an effective treatment for pancreatic cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pancreatic Cancer Chemoresistance to Gemcitabine.
Amrutkar M, Gladhaug IP. · · 2017 · cited 354× · PMID 29144412 · DOI 10.3390/cancers9110157 -
Overall survival and clinical characteristics of pancreatic cancer in BRCA mutation carriers.
Golan T, Kanji ZS, Epelbaum R, Devaud N, et al · · 2014 · cited 317× · PMID 25072261 · DOI 10.1038/bjc.2014.418 -
Drug development in the era of precision medicine.
Dugger SA, Platt A, Goldstein DB. · · 2018 · cited 296× · PMID 29217837 · DOI 10.1038/nrd.2017.226 -
Targeting DNA damage response in cancer therapy.
Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366 -
PARP inhibitors in pancreatic cancer: molecular mechanisms and clinical applications.
Zhu H, Wei M, Xu J, Hua J, et al · · 2020 · cited 203× · PMID 32122376 · DOI 10.1186/s12943-020-01167-9 -
DNA damage repair as a target in pancreatic cancer: state-of-the-art and future perspectives.
Perkhofer L, Gout J, Roger E, Kude de Almeida F, et al · · 2021 · cited 147× · PMID 32855305 · DOI 10.1136/gutjnl-2019-319984 -
Targeting DNA repair pathways for cancer treatment: what's new?
Kelley MR, Logsdon D, Fishel ML. · · 2014 · cited 143× · PMID 24947262 · DOI 10.2217/fon.14.60 -
Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma.
Lowery MA, Kelsen DP, Capanu M, Smith SC, et al · · 2018 · cited 119× · PMID 29223478 · DOI 10.1016/j.ejca.2017.11.004
Verify or expand the search:
- PubMed search for NCT01585805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01585805 (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 National Cancer Institute (NCI)
- Last refreshed: 11 March 2025
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/NCT01585805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing