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NCT01660360
A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer
Phase 1 trial testing Tanibirumab in Advanced Cancer in 26 participants. Completed in 1 September 2013.
1 September 2013
Quick facts
| Lead sponsor | PharmAbcine |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 November 2011 |
| Primary completion | 1 September 2013 |
| Estimated completion | 1 September 2013 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Tanibirumab — full drug profile →
Conditions studied
- Advanced Cancer — all drugs for Advanced Cancer →
- Metastatic Cancer — all drugs for Metastatic Cancer →
Sponsor
PharmAbcine — full company profile →
Who can join
20 and older, any sex, with Advanced Cancer or Metastatic 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.
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Safety and tolerability
Time frame: 28days
The safety and tolerability of Tanibirumab will be assessed using the following measures: frequency and nature of dose-limiting toxicities (DLTs); nature, severity, and relatedness of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0; changes in vital signs; and changes in clinical laboratory parameters.
Sponsor's own description
The primary objective of this study is to assess the safety, tolerability, and maximum tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic option. * To evaluate the pharmacokinetics of Tanibirumab in such patients * To determine a recommended phase II dose (RP2D) of Tanibirumab based on above assessments
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
Verify or expand the search:
- PubMed search for NCT01660360
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other PharmAbcine 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 NCT01660360 (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 PharmAbcine
- Last refreshed: 27 January 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/NCT01660360.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing