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NCT01705483
A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies
Phase 1 trial testing ASP9853 in Pharmacokinetics of ASP9853 in 21 participants. Terminated before completion.
11 June 2014
Quick facts
| Lead sponsor | Astellas Pharma Global Development, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 21 |
| Start date | 28 August 2012 |
| Primary completion | 11 June 2014 |
| Estimated completion | 11 June 2014 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- ASP9853 — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Pharmacokinetics of ASP9853 — all drugs for Pharmacokinetics of ASP9853 →
- Non-hematologic Malignancies — all drugs for Non-hematologic Malignancies →
Sponsor
Astellas Pharma Global Development, Inc. — full company profile →
Who can join
18 and older, any sex, with Pharmacokinetics of ASP9853 or Non-hematologic Malignancies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the safety and tolerability and pharmacokinetics of ASP9853 combined with docetaxel or with paclitaxel in subjects with advanced non-hematologic malignancies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
ASP9853, an inhibitor of inducible nitric oxide synthase dimerization, in combination with docetaxel: preclinical investigation and a Phase I study in advanced solid tumors.
Luke JJ, LoRusso P, Shapiro GI, Krivoshik A, et al · · 2016 · cited 16× · PMID 26811179 · DOI 10.1007/s00280-016-2967-0
Verify or expand the search:
- PubMed search for NCT01705483
- 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 NCT01705483 (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 Astellas Pharma Global Development, Inc.
- Last refreshed: 7 November 2024
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/NCT01705483.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing