Clinical trial · Interventional
A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
NCT00615446CI-TRIAL-00003412completedPhase 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)
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SU011248; Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: SU011248; Gemcitabine
Primary outcomes (1)
- measure
- To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
- timeFrame
- From screening until at least 28 days beyond discontinuation of study treatment
Secondary outcomes (2)
- measure
- To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered
- timeFrame
- From screening until at least 28 days beyond discontinuation of study treatment
- measure
- To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists * Patient has good performance status (ECOG 0 or 1) Exclusion Criteria: * Prior treatment with either gemcitabine or SU011248 * Hypertension that cannot be controlled by medications
References
Publications (1)
- DERIVEDMichaelson MD, Zhu AX, Ryan DP, McDermott DF, Shapiro GI, Tye L, Chen I, Stephenson P, Patyna S, Ruiz-Garcia A, Schwarzberg AB. Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dose-finding study. Br J Cancer. 2013 Apr 16;108(7):1393-401. doi: 10.1038/bjc.2013.96. Epub 2013 Mar 19. PMID 23511559