Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03323710|
Recruitment Status : Withdrawn (Poor patient recruitment.)
First Posted : October 27, 2017
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Propranolol Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Two-stage optimal Simon design|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma (ProSun Study)|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Propranolol plus Sunitinib||
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).
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.
Other Name: Sutent
- Objective Response Rate (ORR) [ Time Frame: Up to 18 months ]Objective Response Rate (ORR) is defined as the percentage of patients who have achieved partial response (PR) or complete response (CR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
- Overall Survival (OS) [ Time Frame: Up to 18 months ]Overall Survival (OS) is defined as the time from treatment initiation to death from any cause.
- Progression-free Survival (PFS) [ Time Frame: Up to 18 months ]Progression-free Survival (PFS) is defined as the time from treatment initiation to the first date of objectively determined progressive disease (PD) according to the RECIST v1.1 or death from any cause, whichever occurred first.
- Disease Control Rate (DCR) [ Time Frame: Up to 18 months ]Disease Control Rate (DCR) is defined as the percentage of patients who have achieved partial response (PR), complete response (CR) or stable disease (SD) according to the RECIST v1.1.
- Safety profile as assessed by Common Terminology Criteria for Adverse Events v4.03 summarized by type, frequency, and severity. [ Time Frame: Up to 18 months ]Safety profile as assessed by Common Terminology Criteria for Adverse Events v4.03 summarized by type, frequency, and severity.
- Health-related Quality of Life (QoL) [ Time Frame: Up to 18 months ]
Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) v3.
The EORTC QLQ-C30 includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range from 0 to 100. High score for a functional scale represents a high / healthy level of functioning. High score for the global health status / QoL represents a high QoL. High score for a symptom scale / item represents a high level of symptomatology / problems. Scoring these scales include the following steps:
- Estimate the average of the items that contribute to the scale (the raw score).
- Use the linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
- Health-related Quality of Life (QoL) [ Time Frame: Up to 18 months ]Change from baseline in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - 15.
- Disease-related Stress (DRS) [ Time Frame: Up to 18 months ]
Change from baseline in the 10-point Perceived Stress Scale (PSS).
The PSS is a validated psychological tool for assessing the perception of stress. Patient responses to all of the 10 questions present in the PSS questionnaire range from 0 to 4. To obtain a total result:
- Reverse scores for questions 4, 5, 7, and 8.
- Add up scores for each question to get a total result. Individual total scores range from 0 to 40. Higher scores indicate higher perceived stress.
- Tumour tissue and serum biomarkers status [ Time Frame: Up to 18 months ]Descriptive statistics of selected biomarkers from analysis of patient samples.
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): NCT03323710
|Military Institute of Medicine|
|Warsaw, Mazowieckie, Poland, 04141|
|Principal Investigator:||Paweł Chrom, M.D.||Military Institute of Medicine, Poland|