Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC

NCT04375150 | Completed Results FDA Drug

• 1 other identifier: A6181232
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated

Conditions

Renal Cell Carcinoma (RCC)

Outcome Measures

Primary Outcomes (17)

• Number of Participants With First Line Treatment Regimen

  Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months

• Number of Participants With Monotherapy and Combination Therapy

  Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Time to First Line Therapy

  Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.

  From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months

• Duration of Treatment According to Each Line of Therapy

  Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants With Treatment Continuation

  Treatment continuation was considered when there was no more than (\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants With Treatment Interruption

  Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Time to Treatment Interruption

  Time from index medication to treatment discontinuation for those within treatment interruptions (\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants With Treatment Switch or Augmentation

  Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants According to Lines of Therapy

  Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)

  Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Number of Participants According to Their Status at End of Follow-up

  Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.

  At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)

• Time to Treatment Failure (TTF)

  TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Percentage of Participants With Treatment Discontinuation

  Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

• Percentage of Participants Alive at 3 Months

  Percentage of participants who were alive at 3 months is reported in this outcome measure.

  At 3 months (data collected and observed retrospectively over 35 months)

• Percentage of Participants Alive at 6 Months

  Percentage of participants who were alive at 6 months is reported in this outcome measure.

  At 3 months (data collected and observed retrospectively over 35 months)

• Percentage of Participants Alive at 12 Months

  Percentage of participants who were alive at 12 months is reported in this outcome measure.

  At 3 months (data collected and observed retrospectively over 35 months)

• Overall Survival

  OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.

  From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

Study Arms (1)

Patients with advanced renal cell carcinoma (RCC)

Drug: Tyrosine kinase inhibitor (TKI); Drug: Immuno-oncology (IO)

Interventions

Tyrosine kinase inhibitor (TKI) DRUG

TKIs

Patients with advanced renal cell carcinoma (RCC)

Immuno-oncology (IO) DRUG

IOs

Patients with advanced renal cell carcinoma (RCC)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with RCC

You may qualify if:

• Age 20 years or older in the year of the index first line therapy prescription.
• or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.
• or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)
• Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.
• Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data

You may not qualify if:

• Received advanced treatment prior to the study index date.
• Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.
• Only one RCC diagnosis in the 12 months prior or one mont post index date.
• Patients with data for analysis (\< 3 months post index date)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer INC

New York, New York, 10017, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Tyrosine Kinase Inhibitors

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)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

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

ClinicalTrials.gov_Inquires@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: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: December 2, 2019
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)