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Trial record 1 of 1 for:    NCT00700258
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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)

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ClinicalTrials.gov Identifier: NCT00700258
Recruitment Status : Recruiting
First Posted : June 18, 2008
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 13, 2008
First Posted Date June 18, 2008
Last Update Posted Date July 9, 2019
Actual Study Start Date January 4, 2008
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2010)
  • Safety: absolute and relative incidence of adverse events [ Time Frame: entire study ]
  • Efficacy: best response, progression-free survival, overall survival [ Time Frame: entire study ]
Original Primary Outcome Measures
 (submitted: June 17, 2008)
Incidence of adverse events [ Time Frame: ongoing ]
Change History Complete list of historical versions of study NCT00700258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2010)
Safety: absolute and relative incidence of therapy interruption [ Time Frame: entire study ]
Original Secondary Outcome Measures
 (submitted: June 17, 2008)
Sequence of anticancer drugs in mRCC [ Time Frame: ongoing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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]
Official Title 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).
Brief 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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition
  • Carcinoma, Renal Cell, Advanced
  • Lymphoma, Mantle-Cell
  • Gastrointestinal Stroma Tumors
Intervention
  • Drug: Temsirolimus
    Non-interventional study. Treatment decision already made before inclusion into the registry.
  • Drug: Sunitinib
    Non-interventional study. Treatment decision already made before inclusion into the registry.
  • Drug: Axitinib
    Non-interventional study. Treatment decision already made before inclusion into the registry.
Study Groups/Cohorts
  • 1
    Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings.
    Intervention: Drug: Temsirolimus
  • 2
    Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting
    Intervention: Drug: Temsirolimus
  • 3
    Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting
    Intervention: Drug: Sunitinib
  • 4
    Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting
    Intervention: Drug: Sunitinib
  • 5
    Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC)
    Intervention: Drug: Axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2013)
1600
Original Estimated Enrollment
 (submitted: June 17, 2008)
500
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with proven tumor of RCC, MCL or GIST by histology.
  • Informed consent signed by patient.

Exclusion Criteria:

  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00700258
Other Study ID Numbers 3066K1-4407
B1771009 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019