Phase 1
Completed N=12
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Source: ClinicalTrials.gov NCT00631410 ↗Enrolled (actual)
12
Serious AEs
50.0%
Results posted
Aug 2010
Primary outcomePrimary: Number of Participants With Adverse Events — 6; 6; 2; 4 participants
Summary
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 6; 2; 4; 6; 6 | — |
| SECONDARY Plasma Concentration of Sunitinib |
85.40; 86.15; 93.35; 98.50; 81.70; 87.05 | — |
| SECONDARY Plasma Concentration of Sunitinib Active Metabolite (SU012662) |
41.75; 36.90; 43.55; 42.35; 42.65; 36.10 | — |
| SECONDARY Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) |
136.25; 123.05; 136.75; 142.35; 132.85; 122.15 | — |
| SECONDARY Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 0; 4; 4; 1; 1 | — |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Sunitinib Relative Dose Intensity in the Treatment Arm A |
57.1; 72.4; 64.3; 53.6; 42.9; 50.0 | — |
| SECONDARY Sunitinib Relative Dose Intensity in the Treatment Arm B |
100.0; 97.1; 78.6; 90.0; 82.1; 73.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
- Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
- Prior surgery or investigational agent within 4 weeks prior to study entry.
- Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
Data sourced from ClinicalTrials.gov (NCT00631410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.