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Validation of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Prognostic Classification for Targeted Therapies (TKI/mTOR Inhibitors) in Second Line After First Line Treatment With Pazopanib (Spazo-2)

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ClinicalTrials.gov Identifier: NCT03091465
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

Brief Summary:

This is a nation-wide retrospective observational study which will be performed in 50 centres in Spain, geographically representative of all regions, with at least 5 patients treated with first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval of pazopanib in Spain), January 2016.

Pazopanib is one of the standard tyrosine-kinase inhibitors (TKI) for the first-line treatment of metastatic renal cell carcinoma. In our previous SPAZO study, the Spanish Oncologic Genitourinary Group (SOGUG) validated the IMDC prognostic classification for patients receiving first-line pazopanib, and demonstrated the effectiveness of this drug in routine clinical practice. However, in this series of 278 patients, we could not obtain enough information on the effectiveness of pazopanib in special subpopulations such as non-clear cell histologies, and others subgroups, due to a small simple size of each of these subpopulations. On the other hand, after the results of RECORD-1 and AXIS trials, switching to everolimus or axitinib is the current approach for patients who progresses to a first-line TKI. However, these pivotal studies did not include patients treated with first-line pazopanib study because this drug was not available at that time. The results of the SPAZO study also suggested that the effectiveness of second-line targeted therapies (TT) after pazopanib in routine clinical practice is similar to the observed in clinical trials after sunitinib, sorafenib or bevacizumab. In addition, the preliminary results indicated that there are not meaningful differences in the effectiveness of TKI or mTOR inhibitors after pazopanib, when the results are adjusted by the IMDC prognostic classification. However, the IMDC prognostic classification for second-line TT has not yet been validated for patients who receive pazopanib as first-line. In addition our sample size was not large enough to make a comparison of effectiveness between mTOR inhibitors and antiVEGF for each prognostic subgroups of the IMDC.

Based on that, the Spanish Oncologic Genitourinary Group has decided to launch the SPAZO-2 study, in which we intend to prolong the follow up of patients included in SPAZO, and to increase the sample size with new patients from new centres, in order to obtain a larger sample in each of the subpopulations of interest, with the objective of obtaining more information about the above questions.


Condition or disease
Metastatic Renal Cell Carcinoma

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Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Prognostic Classification for Targeted Therapies (TKI/mTOR Inhibitors) in Second Line After First Line Treatment With Pazopanib
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib

Group/Cohort
Metastatic Renal Cell Carcinoma patients
This is a nation-wide retrospective observational study with patients treated with first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval of pazopanib in Spain), January 2016.



Primary Outcome Measures :
  1. IMDC prognostic [ Time Frame: 1 day ]
    Validate the IMDC prognostic classification in terms of overall survival, for second line treatment with mTOR/TKI inhibitors after first-line pazopanib. Overall survival defined as the period between second-line targeted therapy initiation and the date of death or censored on the day of last follow up visit, will be indirectly compared to the reported in the IMDC for the overall population and for each IMDC subgroups.


Secondary Outcome Measures :
  1. Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of overall survival (OS). [ Time Frame: 1 day ]
  2. Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of progression-free survival (PFS). [ Time Frame: 1 day ]
  3. Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of response rate (RR). [ Time Frame: 1 day ]
  4. Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of OS. [ Time Frame: 1 day ]
  5. Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of PFS. [ Time Frame: 1 day ]
  6. Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of RR. [ Time Frame: 1 day ]
  7. Safety of pazopanib and mTOR/TKI inhibitors evaluated as the number of patients who present treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
metastatic renal cell carcinoma patients treated with pazopanib as first line treatment and target therapies (TKI/mTOR inhibitors) in second line
Criteria

Inclusion Criteria:

  • 1. Patients with confirmed mRCC. All histologies are allowed.
  • 2. Patients who have received pazopanib in their centre as first TKI for metastatic renal carcinoma in daily clinical practice since its approval in Spain until January 2016 (previous non-TKI therapies such as surgery for metastasis, local radiotherapy, citokines or chemotherapy are allowed.
  • 3. Age ≥18 years.
  • 4. Patients alive should give informed consent to participate in the study and to allow their medical records to be reviewed, preferably in writing o orally before independent witnesses of the research team and after being informed and have sufficient time to decide on their inclusion in the study

Exclusion Criteria:

  • 1. Patients who received pazopanib in any clinical trial, or who had received any systemic therapy prior to pazopanib will not be included, except citoquines or sunitinib providing it had been given as first-line, and switched to pazopanib due to toxicity or intolerance during the first cycle.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091465


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Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group

Publications of Results:
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Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT03091465     History of Changes
Other Study ID Numbers: SOGUG-2016-A-IEC(REN)-4
SOG-PAZ-2016-01 ( Other Identifier: The Spanish Agency of Medicinal Products and Medical Devices )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents