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NCT00476216
Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Phase 1 trial testing Combination of Arixtra with chemotherapy in Non-Small Cell Lung Cancer in 23 participants. Completed in 1 December 2013.
1 December 2012
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 1 September 2007 |
| Primary completion | 1 December 2012 |
| Estimated completion | 1 December 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Combination of Arixtra with chemotherapy — full drug profile →
Conditions studied
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
- Venous Thromboembolism — all drugs for Venous Thromboembolism →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 18 to 79, any sex, with Non-Small Cell Lung Cancer or Venous Thromboembolism. 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.
-
The tolerability and safety of the combination of fondaparinux with standard chemotherapy (carboplatin/paclitaxel).
Time frame: Every 3 weeks prior to each cycle of therapy.
Sponsor's own description
There is a direct association between cancer and thrombosis (blood clots). The purpose of this study is to determine the best dose of an antithrombotic (prevents blood clots) agent called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive chemotherapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Thromboprophylaxis guidelines in cancer with a primary focus on ambulatory patients receiving chemotherapy: a review from the Southern Network on Adverse Reactions (SONAR).
Maxwell WD, Bennett CL. · · 2012 · cited 9× · PMID 23111863 · DOI 10.1055/s-0032-1328893
Verify or expand the search:
- PubMed search for NCT00476216
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-Small Cell Lung Cancer
Currently open trials in the same condition.
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Other University of Alabama at Birmingham 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 NCT00476216 (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 University of Alabama at Birmingham
- Last refreshed: 3 March 2014
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/NCT00476216.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing