Who is sponsoring NCT01028495?

NCT01028495 is sponsored by Rexahn Pharmaceuticals, Inc..

What drugs are being tested in NCT01028495?

Interventions in NCT01028495: RX-0201 plus Gemcitabine.

What condition does NCT01028495 study?

NCT01028495 studies Metastatic Pancreatic Cancer.

Is NCT01028495 still recruiting?

NCT01028495 is currently completed. Last updated 10 September 2019.

Last reviewed 2019-09-10 · How we verify

NCT01028495

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

A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer

Completed Phase 2 Last updated 10 September 2019

What this trial tests

Phase 2 trial testing RX-0201 plus Gemcitabine in Metastatic Pancreatic Cancer in 31 participants. Completed in 1 August 2012.

Timeline

1 May 2009

Primary endpoint
1 July 2012

1 August 2012

Quick facts

Lead sponsor	Rexahn Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	1 May 2009
Primary completion	1 July 2012
Estimated completion	1 August 2012
Sites	10 locations across United States, India

Drugs / interventions tested

RX-0201 plus Gemcitabine — full drug profile →

Conditions studied

Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →

Sponsor

Rexahn Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Survival
Time frame: 7 Months

Sponsor's own description

To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.

Publications & conference data

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

Combating pancreatic cancer with PI3K pathway inhibitors in the era of personalised medicine.
Conway JR, Herrmann D, Evans TJ, Morton JP, et al · · 2019 · cited 75× · PMID 30396902 · DOI 10.1136/gutjnl-2018-316822
Phosphoinositide 3-Kinase Signaling Pathway in Pancreatic Ductal Adenocarcinoma Progression, Pathogenesis, and Therapeutics.
Murthy D, Attri KS, Singh PK. · · 2018 · cited 70× · PMID 29670543 · DOI 10.3389/fphys.2018.00335
Small molecules to the rescue: Inhibition of cytokine signaling in immune-mediated diseases.
Gadina M, Gazaniga N, Vian L, Furumoto Y. · · 2017 · cited 60× · PMID 28676205 · DOI 10.1016/j.jaut.2017.06.006
Molecular targets for the treatment of pancreatic cancer: Clinical and experimental studies.
Matsuoka T, Yashiro M. · · 2016 · cited 39× · PMID 26811624 · DOI 10.3748/wjg.v22.i2.776
Intrinsic and Extrinsic Factors Impacting Cancer Stemness and Tumor Progression.
Ponomarev A, Gilazieva Z, Solovyeva V, Allegrucci C, et al · · 2022 · cited 31× · PMID 35205716 · DOI 10.3390/cancers14040970
Novel approaches in the management of pancreatic ductal adenocarcinoma: potential promises for the future.
Goel G, Sun W. · · 2015 · cited 31× · PMID 25935754 · DOI 10.1186/s13045-015-0141-5
State of the art biological therapies in pancreatic cancer.
Di Marco M, Grassi E, Durante S, Vecchiarelli S, et al · · 2016 · cited 25× · PMID 26798437 · DOI 10.4251/wjgo.v8.i1.55
Clinical and Pre-Clinical Evidence of Carbonic Anhydrase IX in Pancreatic Cancer and Its High Expression in Pre-Cancerous Lesions.
Strapcova S, Takacova M, Csaderova L, Martinelli P, et al · · 2020 · cited 20× · PMID 32707920 · DOI 10.3390/cancers12082005

Verify or expand the search:

Other recruiting trials for Metastatic Pancreatic Cancer

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
NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
NCT06843551 — The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation · Phase 2 · recruiting
NCT06951997 — QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer · Phase 2 · recruiting
NCT06533332 — A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors · Phase 1 · recruiting

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 NCT01028495 (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 Rexahn Pharmaceuticals, Inc.
Last refreshed: 10 September 2019

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/NCT01028495.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing