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. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00700258
First received: June 13, 2008
Last updated: October 2, 2014
Last verified: October 2014
  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 Phase
Carcinoma, Renal Cell, Advanced
Lymphoma, Mantle-Cell
Gastrointestinal Stroma Tumors
Drug: Temsirolimus
Drug: Sunitinib
Drug: Axitinib
Phase 4

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:


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: January 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700258

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Germany
Dr. med. Hans Wilhelm Duebbers Recruiting
Ahaus, Germany, 48683
Dr. Jens-Uwe Krieger Recruiting
Chemnitz, Germany, 09127
Leonhard Stark Recruiting
Deggendorf, Germany, 94469
Dr.med Johannes Mohm Recruiting
Dresden, Germany, 01307
Goebell Recruiting
Erlangen, Germany, 91054
Prof. Dr. med. Lothar Bergmann Recruiting
Frankfurt am Main, Germany, 60596
Hoffkes Recruiting
Fulda, Germany, 36043
Dr. med. Susan Foller Recruiting
Jena, Germany, 07743
Steinmetz Recruiting
Koeln, Germany, 50677
Dr. med. Martina Stauch Recruiting
Kronach, Germany, 96317
Andreas Schwarzer Recruiting
Leipzig, Germany, 04289
Dietel Recruiting
Leipzig, Germany, 04103
Lutz Kamann Recruiting
Leipzig, Germany, 04357
Dr.med. Wolfgang Abenhardt Recruiting
München, Germany, 80335
Herrmann Recruiting
Münster, Germany
Dr.med. Christian Linder Recruiting
Nordhausen, Germany, 99734
Wolfgang Marz Recruiting
Osnabruck, Germany, 49076
Dr.med. Alexander Piotrowski Recruiting
Ostfildern, Germany, 73760
Andreas Hübner Recruiting
Rostock, Germany, 18107
Dr. Matthias Groschek Recruiting
Stolberg, Germany, 52222
Klotz Recruiting
Weiden, Germany, 92637
Dr.med. Jan Janssen Recruiting
Westerstede, Germany, 26655
Jochen Gleissner Recruiting
Wuppertal, Germany, 42103
Mathias Schulze Recruiting
Zittau, Germany, 02763
Scheffler Recruiting
Zwickau, Germany, 08060
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: October 2, 2014
Health Authority: Germany: BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte)

Additional relevant MeSH terms:
Everolimus
Sirolimus
Carcinoma
Carcinoma, Renal Cell
Lymphoma
Lymphoma, Mantle-Cell
Adenocarcinoma
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Kidney Neoplasms
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Axitinib
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 21, 2014