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

NCT03140176 | Terminated Results FDA Drug

• 1 other identifier: A6181223
• Study Type: observational
• Target: 77
• Locations: 4 countries
• Sites: 8

Brief Summary

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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Sunitinib; Metastatic Renal Cell Carcinoma; Africa Middle East

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  PFS was defined as the time from when the participant received the first dose of sunitinib to the time of progression or death due to any cause, which occurred first. The time of progression was the date of the first tumor assessment where the progression was notified as response to therapy, over the sunitinib treatment. Participants who discontinued the study for any reason, including unacceptable toxicity during the treatment period, who remained alive and without disease progression, were censored at the last disease assessment that verified lack of disease progression. As per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 millimeters \[mm\]) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.

  From date of first dose of sunitinib to date of progression or death or censored date, whichever occurred first (up to maximum of 36 months)

• Time to Treatment Failure (TTF)

  TTF was defined as the time from when the participant received the first dose of sunitinib to the time of sunitinib discontinuation (date completed by the physician). In case of death when the participant was still treated with sunitinib, date of death was considered as date of discontinuation. If no sunitinib discontinuation was reported during the follow-up visits, participants were censored to the last follow-up visit.

  From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)

Secondary Outcomes (30)

• Objective Response Rate (ORR) at Months 3, 6, 9 and 12

  Months 3, 6, 9 and 12

• Number of Participants With Recommended Starting Dose of Sunitinib

  At initiation of sunitinib (Day 0)

• Number of Participants With Other Starting Doses

  At initiation of sunitinib (Day 0)

• Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose

  At initiation of sunitinib (Day 0)

• Average Dose Received Over the Sunitinib Treatment Period

  During treatment period (up to 12 months)

Interventions

Sunitinib DRUG

Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.

Also known as: Sutent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.

You may qualify if:

• Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
• Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Pierre Et Marie Curie Center

Algers, 16005, Algeria

Location

CAC Annaba

Annaba, Algeria

Location

Hanene Djedi

Annaba, Algeria

Location

Kasr Al Aini

Cairo, 11562, Egypt

Location

National Cancer Institute

Cairo, 11796, Egypt

Location

Demerdash Hospital

Cairo, Egypt

Location

Kuwait Cancer Control Center

Kuwait City, 70653, Kuwait

Location

Institut National D'Oncologie

Rabat, Morocco

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: August 15, 2017
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: May 10, 2024
• Results First Posted: May 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AL (3); EG (3); KU (1); MO (1)