Who is sponsoring NCT01964287?

NCT01964287 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle.

What drugs are being tested in NCT01964287?

Interventions in NCT01964287: GEMBRAX, FOLFIRINOX.

What condition does NCT01964287 study?

NCT01964287 studies Metastatic Pancreatic Adenocarcinoma.

Is NCT01964287 still recruiting?

NCT01964287 is currently completed. Last updated 31 December 2020.

Last reviewed 2020-12-31 · How we verify

NCT01964287: GABRINOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

Completed Phase 1, PHASE2 Last updated 31 December 2020

What this trial tests

Phase 1, PHASE2 trial testing GEMBRAX in Metastatic Pancreatic Adenocarcinoma in 78 participants. Completed in 30 December 2020.

Timeline

24 September 2013

Primary endpoint
22 December 2016

30 December 2020

Quick facts

Lead sponsor	Institut du Cancer de Montpellier - Val d'Aurelle
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	24 September 2013
Primary completion	22 December 2016
Estimated completion	30 December 2020
Sites	1 location across France

Drugs / interventions tested

GEMBRAX — full drug profile →
FOLFIRINOX (folfirinox) — full drug profile →

Conditions studied

Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Trial Watch: Chemotherapy with immunogenic cell death inducers.
Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 123× · PMID 24800173 · DOI 10.4161/onci.27878
Metastatic pancreatic cancer: Is there a light at the end of the tunnel?
Vaccaro V, Sperduti I, Vari S, Bria E, et al · · 2015 · cited 49× · PMID 25944992 · DOI 10.3748/wjg.v21.i16.4788
Sequential first-line treatment with nab-paclitaxel/gemcitabine and FOLFIRINOX in metastatic pancreatic adenocarcinoma: GABRINOX phase Ib-II controlled clinical trial.
Assenat E, de la Fouchardière C, Portales F, Ychou M, et al · · 2021 · cited 19× · PMID 34837745 · DOI 10.1016/j.esmoop.2021.100318
A randomized phase II study of weekly nab-paclitaxel plus gemcitabine or simplified LV5FU2 as first-line therapy in patients with metastatic pancreatic cancer: the AFUGEM GERCOR trial.
Bachet JB, Chibaudel B, Bonnetain F, Validire P, et al · · 2015 · cited 10× · PMID 26445094 · DOI 10.1186/s12885-015-1656-4
Recent advances in pancreatic cancer: updates and insights from the 2015 annual meeting of the American Society of Clinical Oncology.
Abrams MJ, Rakszawski K, Vasekar M, Passero F, et al · · 2016 · cited 8× · PMID 26929776 · DOI 10.1177/1756283x15622601
Reply to the comment on 'Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort'.
Pernot S, Bachet JB, Portal A, Taieb J. · · 2016 · cited 4× · PMID 27124338 · DOI 10.1038/bjc.2016.70

Verify or expand the search:

Other recruiting trials for Metastatic Pancreatic Adenocarcinoma

Currently open trials in the same condition.

NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
NCT07226856 — BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent P · Phase 2 · recruiting
NCT07189195 — TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory · Phase 1 · recruiting
NCT06396091 — A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer · Phase 1 · active not recruiting
NCT06381154 — Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or · Phase 2 · recruiting

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01964287 (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 Institut du Cancer de Montpellier - Val d'Aurelle
Last refreshed: 31 December 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/NCT01964287.

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