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Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma

NCT03323710 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-01-09

No results posted yet for this study

Summary

The study aims to assess antineoplastic efficacy, safety, influence on quality of life and disease-related stress of propranolol taken in combination with sunitinib in previously untreated metastatic renal cell carcinoma

Conditions

Interventions

DRUG

Propranolol

Propranolol will be administered orally at a starting dose of 40 mg (one tablet) two times a day (total daily dose of 80 mg). In case of acceptable safety profile, the dose may be increased to 80 mg (two tablets) two times a day (total daily dose of 160 mg) or farther to 80 mg (two tablets) three times a day (total daily dose of 240 mg).

DRUG

Sunitinib

Sunitinib will be administered orally at a starting dose of 50 mg once daily, for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks.The schedule may be changed to 2 weeks on / 1 week off (schedule 2/1) and a daily dose may be reduced to 37.5 mg or 25 mg to decrease the level of toxic side effects.

Sponsors & Collaborators

  • Military Institute od Medicine National Research Institute

    lead OTHER

Principal Investigators

  • Paweł Chrom, M.D. · Military Institute od Medicine National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323710 on ClinicalTrials.gov