Clinical trial · Interventional
A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies
Phase 1 Study Of Sunitinib (SU011248) In Combination With Pemetrexed In Patients With Advanced Solid Malignancies In Japan
NCT00732992CI-TRIAL-00004578completedPhase 1Results postedClinicalTrials.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 will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.
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 |
|---|---|---|---|
| Neoplasm, Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib, Pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CDD
- interventionNames
- Drug: Sunitinib, Pemetrexed
- type
- EXPERIMENTAL
- label
- 2/1
- interventionNames
- Drug: Sunitinib, Pemetrexed
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- End of study (up to individual discontinuation)
- description
- Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of a solid malignancy that is refractory to standard therapy or for which no standard therapy exists. * Patients has a good performance status (ECOG 0 or 1) Exclusion Criteria: * Prior treatment with either pemetrexed or SU011248. * Coughing up blood within 4 weeks before starting study treatment (small amounts okey). * Hypertension that cannot be controlled by medications.
References
Publications (1)
- DERIVEDOkamoto I, Shimizu T, Miyazaki M, Tsurutani J, Ichikawa Y, Terashima M, Takeda M, Fumita S, Ohki E, Kimura N, Hashimoto J, Nakagawa K. Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2012 Apr;30(2):639-46. doi: 10.1007/s10637-010-9565-5. Epub 2010 Oct 20. PMID 20960028