Clinical trial
STAR-TOR- REGISTRY FOR THE EVALUATION OF THE SAFETY, TOLERABILITY AND EFFICACY OF TEMSIROLIMUS (TORISEL), SUNITINIB (SUTENT) AND AXITINIB (INLYTA) FOR THE TREATMENT OF SUBJECTS WITH ADVANCED RENAL CELL CARCINOMA (MRCC), MANTLE CELL LYMPHOMA (MCL) AND GASTRO-INTESTINAL STROMA TUMOR (GIST).
Name
3066K1-4407
Description
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
Trial arms
Trial start
2008-02-13
Estimated PCD
2021-12-28
Trial end
2021-12-28
Status
Completed
Treatment
Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
Arms:
1
Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
Arms:
2
Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Arms:
3
Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Arms:
4
Axitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Arms:
5
Size
1520
Primary endpoint
Safety: absolute and relative incidence of adverse events
entire study
Efficacy: best response, progression-free survival, overall survival
entire study
Eligibility criteria
Inclusion Criteria:
* Patients with proven tumor of RCC, MCL or GIST by histology.
* Informed consent signed by patient.
Exclusion Criteria:
* Pregnancy
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1520, 'type': 'ACTUAL'}}
Updated at
2022-12-05
1 organization
3 products
6 indications
Organization
PfizerProduct
TemsirolimusIndication
cancerIndication
Renal CellIndication
AdvancedIndication
lymphomaIndication
Mantle CellIndication
Gastrointestinal Stromal TumorsProduct
SunitinibProduct
Axitinib