CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Vatalanib +1 moredrug
Likely dose
Vatalanib 500 mg orally twice daily (after 7-day lead-in at 250 mg BID) plus gemcitabine 850 mg/m²AI-extracted
Key inclusion· 10
  • ✓Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • ✓Unresectable disease due to vascular involvement, adjacent organ invasion, or metastasis
  • ✓WHO performance status 0 to 2
  • ✓Absolute Neutrophil Count ≥1.5 × 10⁹/L
Key exclusion· 14
  • ✕Phase 1: prior gemcitabine therapy; Phase 2: any prior chemotherapy except low-dose 5-FU as radiosensitizer
  • ✕Prior full field radiotherapy ≤4 weeks or limited field radiotherapy ≤2 weeks prior to enrollment
  • ✕Prior biologic or immunotherapy ≤2 weeks prior to registration
  • ✕Prior therapy with anti-VEGF agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00185588
NCT00185588Phase 2Completed
CompareCT.gov

A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 <Vatalanib> and Gemcitabine in Patients With Advanced Pancreatic Cancer

George Albert Fisher·interventional·Posted Sep 16, 2005·Updated Sep 15, 2014

In Brief

A Phase 2 clinical trial evaluating Vatalanib and Gemcitabine for Pancreatic Cancer. Completed, enrolled 33 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartOct 1, 2004
Primary CompletionJan 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Vatalanibdrug

Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours

Gemcitabinedrug

850 mg/m2