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)

May 21, 2024 updated by: Pfizer

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).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ahaus, Germany, 48683
        • Dr. med. Hans Wilhelm Duebbers
      • Amberg, Germany, 92224
        • Dr. Ludwig Fischer von Weikersthal
      • Aschaffenburg, Germany, 63739
        • Group Practice Doctors Klausmann
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie
      • Bautzen, Germany, 02625
        • Office of Detlef Muller
      • Bayreuth, Germany, 95445
        • Medilei GmbH
      • Berlin, Germany, 10117
        • Universitaetsklinikum Charite Campus
      • Bernburg, Germany, 06406
        • Carsten Lange
      • Chemnitz, Germany, 09117
        • Office of Axel Belusa
      • Chemnitz, Germany, 09119
        • Office of Ulrich Kube
      • Chemnitz, Germany, 09127
        • Dr. Jens-Uwe Krieger
      • Chemnitz, Germany, 09130
        • Zeisigwaldklinikum Bethanien Chemnitz
      • Deggendorf, Germany, 94469
        • Leonhard Stark
      • Dessau, Germany, 06846
        • Prof. Dr. med. Udo Rebmann
      • Dresden, Germany, 01127
        • doctor's office Dr. Göhler
      • Dresden, Germany, 01307
        • Dr.med Johannes Mohm
      • Eisleben, Germany, 06295
        • Dr. med. Ralf Eckert
      • Erfurt, Germany, 99084
        • Specialist Urology
      • Erlangen, Germany, 91054
        • Goebell
      • Frankfurt am Main, Germany, 60596
        • Prof. Dr. med. Lothar Bergmann
      • Frankfurt am Main, Germany, 65929
        • Dr. med. Gunter Derigs
      • Fulda, Germany, 36043
        • Hoffkes
      • Greifswald, Germany, 17475
        • PD Dr. Uwe Zimmermann
      • Guestrow, Germany, 18273
        • Internistische Gemeinschaftspraxis
      • Göttingen, Germany, 37075
        • Dr. med. Arne Strauss
      • Hamburg, Germany, 20246
        • Dr. med. Michael Rink
      • Hameln, Germany, 31785
        • Office of Oleg Rubanov
      • Hof, Germany, 95028
        • Dr. med. Hanns-Detlev Harich
      • Homburg/Saar, Germany, 66421
        • Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
      • Jena, Germany, 07743
        • Dr. med. Susan Foller
      • Kaiserslautern, Germany, 67655
        • Office of Richard Hansen
      • Koeln, Germany, 50677
        • Steinmetz
      • Koeln, Germany, 50937
        • Klinisches Studienzentrum Urlogie
      • Kronach, Germany, 96317
        • Dr. med. Martina Stauch
      • Landshut, Germany, 84028
        • Dr. med. Ursula Vehling-Kaiser
      • Langen, Germany, 63225
        • Dr. Andreas Kohler
      • Leipzig, Germany, 04103
        • Dietel
      • Leipzig, Germany, 04289
        • Andreas Schwarzer
      • Leipzig, Germany, 04357
        • Resident Doctor
      • Luckenwalde, Germany, 14943
        • DRK Krankenhaus Luckenwalde
      • Markkleeberg, Germany, 04416
        • Dr.med. Matthias Schulze
      • Mayen, Germany, 56727
        • Institut of Healthcare Research
      • Moers, Germany, 47441
        • OnkoLog GbR
      • Mulheim, Germany, 45468
        • Dr. med. Jan Klaus Schroder
      • Mutlangen, Germany, 73557
        • Stauferklinikum Schwaebisch Gmuend
      • München, Germany, 80335
        • Dr.med. Wolfgang Abenhardt
      • Münster, Germany
        • Boegemann
      • Neckarsulm, Germany, 74172
        • Dr. med. Thomas Gehring
      • Neunkirchen, Germany, 66538
        • Dres. Derouet Poenicke Becker
      • Neuwied, Germany, 56564
        • Physician for Internal Medicine
      • Nienburg, Germany, 31582
        • Dr. med. David Kunst
      • Nordhausen, Germany, 99734
        • Dr.med. Christian Linder
      • Nürnberg, Germany, 90449
        • Dr. med. Joachim Zimber
      • Oldenburg, Germany, 26121
        • Ralf-Bodo Kühn
      • Osnabruck, Germany, 49076
        • Prof. Dr. med. Ruhnke
      • Ostfildern, Germany, 73760
        • Dr. med. Torsten Geyer
      • Parchim, Germany, 19370
        • Dr. med. Ino Kietz
      • Plauen =, Germany, D-08523
        • Praxis
      • Recklinghausen, Germany, 45659
        • Oncologianova GmbH
      • Rostock, Germany, 18107
        • Andreas Hübner
      • Saalfeld, Germany, 07318
        • Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie
      • Schwäbisch Hall, Germany, 74523
        • Diakonie-Klinikum gGmbH
      • Schwäbisch Hall, Germany, 74523
        • Dr. med. Thomas Geer
      • Soest, Germany, 59494
        • MVZ Kloster Paradiese GbR
      • Speyer, Germany, 67346
        • Office of Judith Franz-Werner
      • Stolberg, Germany, 52222
        • Dr. Matthias Groschek
      • Trier, Germany, 54292
        • Dr. med. Heinz Kirchen
      • Tuebingen, Germany, 72076
        • Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,
      • Weiden, Germany, 92637
        • Klotz
      • Westerstede, Germany, 26655
        • Dr.med. Jan Janssen
      • Wilhelmshaven, Germany, 26389
        • ZAS - Zentrum fuer angewandte Studien
      • Wuerzburg, Germany, 97070
        • Universitaetsklinik Wuerzburg, Medizinische Poliklinik
      • Wuppertal, Germany, 42103
        • Jochen Gleissner
      • Zittau, Germany, 02763
        • Mathias Schulze
      • Zwickau, Germany, 08060
        • Scheffler
    • Baden-württemberg
      • Ulm, Baden-württemberg, Germany, 89070
        • Universitätsklinikum Ulm
    • Schleswig-holstein
      • Neumuenster, Schleswig-holstein, Germany, 24534
        • Dr. med. Harald Held

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Progression Free Survival (PFS)
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants With Best Overall Response (BOR)
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Karnofsky Performance Status (KPS) Scale
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Who Discontinued Treatment Due to Adverse Events
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Number of Participants Categorized According to Physician's Global Tolerability Assessment
Time Frame: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.
From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Hematology Parameters: Hemoglobin
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH)
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion
Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)
Time Frame: Week 46 up to Week 55 post study inclusion
Week 46 up to Week 55 post study inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: absolute and relative incidence of therapy interruption
Time Frame: entire study
entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2008

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimated)

June 18, 2008

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3066K1-4407
  • B1771009 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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