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]
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00700258
First received: June 13, 2008
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Carcinoma, Renal Cell, Advanced Lymphoma, Mantle-Cell Gastrointestinal Stroma Tumors |
Drug: Temsirolimus Drug: Sunitinib Drug: Axitinib |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | STAR-TOR - Registry for the Evaluation of the Safety, Tolerability and Efficacy of Temsirolimus (Torisel®), Sunitinib (Sutent®), and Axitnib (Inlyta®) for the Treatment of Subjects With Advanced Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), and Gastro-Intestinal Stroma Tumor (GIST) |
Resource links provided by NLM:
Drug Information available for:
Sirolimus
Everolimus
Temsirolimus
Axitinib
Sunitinib malate
Sunitinib
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety: absolute and relative incidence of adverse events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
- Efficacy: best response, progression-free survival, overall survival [ Time Frame: entire study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: absolute and relative incidence of therapy interruption [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1600 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings.
|
Drug: Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
|
|
2
Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting
|
Drug: Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
|
|
3
Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting
|
Drug: Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
|
|
4
Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting
|
Drug: Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
|
|
5
Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC)
|
Drug: Axitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
|
Detailed Description:
Survival time analysis
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST)
Gastro-Intestinal Stroma Tumor
Criteria
Inclusion Criteria:
- Patients with proven tumor of RCC, MCL or GIST by histology.
- Informed consent signed by patient.
Exclusion Criteria:
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700258
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Germany | |
| Pfizer Investigational Site | Recruiting |
| Jena, Germany, 07740 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00700258 History of Changes |
| Other Study ID Numbers: | 3066K1-4407, B1771009 |
| Study First Received: | June 13, 2008 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Germany: BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Lymphoma Lymphoma, Mantle-Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Sirolimus Everolimus Sunitinib Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013