Phase 2
Completed N=82
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Source: ClinicalTrials.gov NCT00494091 ↗Enrolled (actual)
82
Serious AEs
39.0%
Results posted
Jul 2012
Primary outcomePrimary: Percentage of Participants With Clinical Benefit — 50.0; 48.7 percentage of participants
Summary
This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Benefit |
50.0; 48.7 | — |
| SECONDARY Progression-free Survival (PFS) |
8.7; 7.3 | — |
| SECONDARY Percentage of Participants With Objective Response |
0; 11.8 | — |
| SECONDARY Duration of Response |
31.3 | — |
| SECONDARY Time to Treatment Failure (TTF) |
7.7; 5.4 | — |
| SECONDARY Overall Survival (OS) |
29.1; 17.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used.
- ECOG performance status of 0-1.
- At least one measurable lesion per RECIST.
- Age greater than or equal to 20 years.
- Japanese, Chinese, or Korean ethnicity.
Exclusion Criteria
- CNS metastases at screening or history or CNS metastases.
- Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC.
- In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
Data sourced from ClinicalTrials.gov (NCT00494091). 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.