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NCT00454649
A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors
Phase 1 trial testing Axitinib + Paclitaxel + Carboplatin (Cohort 1) in Neoplasms in 102 participants. Completed in 1 April 2011.
1 August 2009
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 1 December 2005 |
| Primary completion | 1 August 2009 |
| Estimated completion | 1 April 2011 |
| Sites | 13 locations across United States, Poland, Spain |
Drugs / interventions tested
- Axitinib + Paclitaxel + Carboplatin (Cohort 1)
- Axitinib + Paclitaxel + Carboplatin (Cohort 2)
- Axitinib + Paclitaxel + Carboplatin (Cohort 3)
- Axitinib + Paclitaxel (Cohort 4) — full drug profile →
- Axitinib + Docetaxel + Carboplatin (Cohort 4a) — full drug profile →
- Axitinib + Docetaxel (Cohort 5) — full drug profile →
- Axitinib + Capecitabine (Cohort 6) — full drug profile →
- Axitinib + Capecitabine (Cohort 7)
- Axitinib + Gemcitabine + Cisplatin (Cohort 8) — full drug profile →
- Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Conditions studied
- Neoplasms — all drugs for Neoplasms →
Sponsor
Pfizer — full company profile →
Who can join
18 and older, any sex, with Neoplasms. 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.
-
Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy
Time frame: Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]
MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\>=) Gr 3 nonhematological toxicities or \>=0.5 teaspoon/day hemoptysis or \>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 day
Sponsor's own description
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours.
Kozloff MF, Martin LP, Krzakowski M, Samuel TA, et al · · 2012 · cited 25× · PMID 22990652 · DOI 10.1038/bjc.2012.406 -
Phase I study of axitinib combined with paclitaxel, docetaxel or capecitabine in patients with advanced solid tumours.
Martin LP, Kozloff MF, Herbst RS, Samuel TA, et al · · 2012 · cited 15× · PMID 22996612 · DOI 10.1038/bjc.2012.407
Verify or expand the search:
- PubMed search for NCT00454649
- 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 NCT00454649 (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 Pfizer
- Last refreshed: 30 March 2012
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/NCT00454649.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing