Clinical trialPhase 1 / Phase 2Completed
Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer
A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 and Gemcitabine in Patients With Advanced Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- October 2004
- Expected end
- December 2009
- Enrollment
- 33 participants
- Sites
- 1
- Primary outcomes
- Time-to-Treatment Failure (Intent-To-Treat Analysis)
- Sponsor
- Other
- Results posted
- 2014-09-15
- Last update
- 15 September 2014
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Brief summary public domain (ClinicalTrials.gov)
The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Time-to-Treatment Failure (Intent-To-Treat Analysis) [12 months]. Median, months (Full Range). Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 (n=6): 4.9 (3.8 to 9.5); Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 (n=4): 2.7 (0.7 to 9.8); Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 (n=6): 2.2 (0.7 to 5.6); Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500 (n=17): 3.7 (0.7 to 10.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time-to-Progression, Evaluable Patients [12 months]. Median, months (Full Range). Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 (n=3): 4.4 (3.8 to 6.0); Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 (n=2): 6.0 (2.1 to 9.8); Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500 (n=13): 3.2 (0.7 to 8.3).