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Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors (US NIS Cabo)

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ClinicalTrials.gov Identifier: NCT04353765
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
To demonstrate cabozantinib efficacy when administrated as treatment for metastatic Renal Cell Carcinoma (mRCC) after prior therapy with Check Point Inhibitors (CPIs)

Condition or disease Intervention/treatment
Locally Advanced or Metastatic Renal Cell Carcinoma Drug: Cabozantinib monotherapy Drug: All authorized TKI monotherapies in advanced RCC: sunitinib (Sutent), Pazopanib (Votrient), Axitinib (Inlyta); Lenvatinib (Lenvima) in combination with everolimus (Afinitor), sorafenib (Nexavar)

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020


Group/Cohort Intervention/treatment
cabozantinib arm Drug: Cabozantinib monotherapy
Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Other Name: Cabometyx

non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm Drug: All authorized TKI monotherapies in advanced RCC: sunitinib (Sutent), Pazopanib (Votrient), Axitinib (Inlyta); Lenvatinib (Lenvima) in combination with everolimus (Afinitor), sorafenib (Nexavar)
As per authorized FDA label in advanced RCC




Primary Outcome Measures :
  1. 6 months Response Rate [ Time Frame: From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: From start of index treatment until end of the treatment or death whichever occurs first ]
  2. Progression Free Survival [ Time Frame: From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease ]
  3. Overall Survival [ Time Frame: From start of index treatment until death or end of the study whichever occurs first ]
  4. Duration of Response [ Time Frame: From date of index treatment response and the earliest date of progressive disease ]
  5. Treatment duration [ Time Frame: From start of index treatment until treatment discontinuation ]
  6. Treatment discontinuation due to toxicity [ Time Frame: From start of index treatment until treatment discontinuation ]
  7. Treatment dose reductions [ Time Frame: From start of index treatment until treatment discontinuation ]
  8. Rate of hospitalisations [ Time Frame: From start of index treatment until treatment discontinuation ]


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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
USON network
Criteria

Inclusion Criteria:

  • Evidence of metastatic Renal Cell Carcinoma (mRCC)
  • Receipt of Check Point Inhibitors as the latest treatment for mRCC administrated before index treatment: Tyrosine Kinase Inhibitors
  • Receipt of Tyrosine Kinase Inhibitors
  • Patients who received care at a US Oncology Network site

Exclusion Criteria:

  • Age below 18 years old
  • Patients enrolled in a clinical trial at any time during index treatment
  • Patients receiving treatment for another documented primary cancer diagnoses during the study

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): NCT04353765


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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United States, Texas
McKesson Life Sciences Recruiting
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04353765    
Other Study ID Numbers: F-FR-60000-066
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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
Everolimus
Sorafenib
Sunitinib
Lenvatinib
Axitinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors