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]

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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).

ClinicalTrials.gov ID

NCT00700258

Acronym / sponsor ID

STAR-TOR / 3066K1-4407

Conditions

Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors

Study type

Observational

Recruitment status

Completed

Enrolment

1,520 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

13 Feb 2008 (actual)

Primary completion

28 Dec 2021 (actual)

Study completion

28 Dec 2021 (actual)

First posted

18 Jun 2008 (estimated)

Results

Posted 23 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

5

Who may qualify

Ages

18 to 99 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST) Gastro-Intestinal Stroma Tumor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit

    Time frame: Week 46 up to Week 55 post study inclusion

11. Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)

    Time frame: Week 46 up to Week 55 post study inclusion

12. Absolute Laboratory Values of Hematology Parameters: Hemoglobin

    Time frame: Week 46 up to Week 55 post study inclusion

13. 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

14. Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin

    Time frame: Week 46 up to Week 55 post study inclusion

15. 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

16. Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin

    Time frame: Week 46 up to Week 55 post study inclusion

17. Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4)

    Time frame: Week 46 up to Week 55 post study inclusion

18. Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)

    Time frame: Week 46 up to Week 55 post study inclusion

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 38310863Uhlig A, Bergmann L, Bogemann M, Fischer T, Goebell PJ, Leitsmann M, Reichert M, Rink M, Schlack K, Trojan L, Uhlig J, Woike M, Strauss A. Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review. Urol Int. 2024;108(3):198-210. doi: 10.1159/000536563. Epub 2024 Feb 2.
• Derived from this study: PubMed 33724867Strauss A, Schmid M, Rink M, Moran M, Bernhardt S, Hubbe M, Bergmann L, Schlack K, Boegemann M. Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry. Future Oncol. 2021 Jun;17(18):2325-2338. doi: 10.2217/fon-2020-1020. Epub 2021 Mar 16.
• Derived from this study: PubMed 33021843Boegemann M, Schlack K, Rink M, Bernhardt S, Moran M, Hubbe M, Bergmann L, Schmid M, Strauss A. Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry. Future Oncol. 2020 Dec;16(35):2939-2948. doi: 10.2217/fon-2020-0548. Epub 2020 Oct 6.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

77 sites in 1 country: see every site and its status.