Trial record 2 of 6 for:    GIST registry

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] (STAR-TOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00700258
First received: June 13, 2008
Last updated: July 11, 2016
Last verified: July 2016
  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:


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: December 2017
Estimated Primary Completion Date: September 2017 (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:

Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines.

Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib.

The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, 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.

Therefore, the following information is of particular interest in the course of the investigation:

  • Efficacy (best response, overall survival, progression-free survival)
  • Tolerability of the therapy (assessed by the physician)
  • Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta®
  • Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta®
  • The sequence of using the systemic therapies for RCC, MCL, and GIST
  • Patient survey on the quality of life of mRCC patients
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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

  Show 65 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: July 11, 2016
Health Authority: Germany: BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte)

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Lymphoma
Carcinoma
Lymphoma, Mantle-Cell
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Lymphoma, Non-Hodgkin
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Everolimus
Sirolimus
Axitinib

ClinicalTrials.gov processed this record on July 21, 2016