N/A
N=1,520
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
Carcinoma, Renal Cell, Advanced · Lymphoma, Mantle-Cell · Gastrointestinal Stroma Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00700258 ↗Enrolled (actual)
1,520
Serious AEs
43.0%
Results posted
Sep 2024
Primary outcome: Primary: Overall Survival (OS) — 11.04; 25.36; 18.37; 15.11 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Temsirolimus (Drug); Sunitinib (Drug); Axitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
11.04; 25.36; 18.37; 15.11; 16.30 | — |
| PRIMARY Progression Free Survival (PFS) |
3.91; 6.93; 5.75; 3.68; 10.32 | — |
| PRIMARY Number of Participants With Best Overall Response (BOR) |
5; 40; 3; 1; 0; 70 | — |
| PRIMARY Number of Participants Categorized According to Physician's Global Assessment of Effectiveness |
35; 57; 6; 2; 0; 176 | — |
| PRIMARY Karnofsky Performance Status (KPS) Scale |
71.9; 78.8; 77.9; 77.8 | — |
| PRIMARY Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma |
5; 24; 13; 6 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
460; 585; 187; 53; 20; 269 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to Adverse Events |
108; 142; 60; 17; 5 | — |
| PRIMARY Number of Participants Categorized According to Physician's Global Tolerability Assessment |
93; 49; 21; 5; 3; 306 | — |
| PRIMARY Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit |
67.1; 56.0; 64.4; 58.7; 58.7; 18.8 | — |
| PRIMARY Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c) |
7.9; 5.8; 5.9; 7.5 | — |
| PRIMARY Absolute Laboratory Values of Hematology Parameters: Hemoglobin |
11.2; 12.2; 14.4; 12.6; 11.9 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose |
2.3; 2.3; 2.6; 2.4; 2.3; 136.0 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin |
1.4; 1.4; 1.3; 0.7; 1.1; 0.9 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) |
20.2; 25.9; 34.7; 24.0; 22.9; 23.1 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin |
31.1; 33.6; 31.6; 42.0 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) |
3.5; 3.7; 3.8; 15.4; 14.8; 13.7 | — |
| PRIMARY Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH) |
1.5; 3.5; 3.4; 1.6 | — |
Summary
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use
Eligibility Criteria
Inclusion Criteria
- Patients with proven tumor of RCC, MCL or GIST by histology.
- Informed consent signed by patient.
Exclusion Criteria
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00700258). 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.