Phase 1
Completed N=22
Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00291577 ↗Enrolled (actual)
22
Serious AEs
50.0%
Results posted
Dec 2009
Primary outcomePrimary: Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters — 6.0; 6.0; 6.0; 6.0 hours
Summary
This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters |
6.0; 6.0; 6.0; 6.0; 6.0; 6.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters |
29.17; 29.49; 5.07; 5.91; 34.05; 34.69 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters |
486.38; 479.80; 82.21; 96.88; 568.78; 567.43 | — |
| PRIMARY Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters |
— | — |
| PRIMARY Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters |
52.06; 5.00; 21.75; 4.88; 0.20; 73.81 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters |
0.70; 0.77 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters |
2932.00; 2955.38 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters |
2918.09; 3101.69 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters |
3167.53; 3326.98 | — |
| PRIMARY Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters |
249.45; 225.29 | — |
| PRIMARY Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters |
3159.58; 3304.48 | — |
| PRIMARY Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters |
22.55; 24.88 | — |
| SECONDARY Progression-Free Survival (PFS) Based on Investigator Assessment |
34.9 | — |
| SECONDARY Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment |
14 | — |
| SECONDARY Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment |
17 | — |
| SECONDARY Duration of Tumor Response Based on Investigator Assessment |
28.7 | — |
Eligibility Criteria
Inclusion Criteria
- Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
- Candidate for treatment with docetaxel
Exclusion Criteria
- Prior chemotherapy in the advanced disease setting
- Inflammatory breast cancer
- HER2 positive disease
Data sourced from ClinicalTrials.gov (NCT00291577). 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.