Clinical trial · Interventional
Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
NCT00681798CI-TRIAL-00023688completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Dose level 1
- description
- Vandetanib 100mg/day plus Gemcitabine
- interventionNames
- Drug: Vandetanib
- type
- ACTIVE_COMPARATOR
- label
- Dose level 2
- description
- Vandetanib 300mg/day plus Gemcitabine
- interventionNames
- Drug: Vandetanib
- type
- ACTIVE_COMPARATOR
- label
- Dose level 3
- description
- Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma * ECOG performance status \<1 * Measurable disease Exclusion Criteria: * Severe or uncontrolled systemic disease * Clinically significant cardiac event such as myocardial infarction * Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
References
Publications (1)
- BACKGROUNDSaletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15. PMID 21921646