Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy. (OPTIMISE)

Pfizer

Status: Terminated

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: Sunitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03140176

A6181223

Details and patient eligibility

About

OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to efficacy outcomes, adverse events, and health related QoL in the real life setting.

Full description

OPTIMISE study objectives are dual and aim primarily to increase the knowledge regarding the outcomes from Sunitinib use on one hand; and outcomes from the combined Sunitinib-2nd line sequence on the other hand in real life clinical practice.

This will be addressed in many countries across AfME and in individual country cohorts to understand specificities and differences in use and outcomes

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  1. Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.

  2. Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1

  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

     Exclusion Criteria:

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  1. Patients being treated with cytokines or any other treatment other than SU in 1st line setting
  2. Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.

Trial design