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Renal Cell CarcinomaPhase 2NCT03323710

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

A Phase 2 study testing Propranolol and Sunitinib in people with Renal Cell Carcinoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Propranolol and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 sitePoland
Study dates
Sep 2018to Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if they meet all of the following criteria:
  • Histological diagnosis of clear-cell renal cell carcinoma (RCC) or mixed-type RCC with more than 60% of clear-cell component.
  • Diagnosis of stage IV RCC (primary metastatic or recurrence after surgical procedure).
  • Prior nephrectomy (complete or partial).
  • Presence of measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1.
  • Karnofsky performance status score of 80-100%.
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  • Favourable- or intermediate-risk according to Memorial Sloan Kettering Cancer Center criteria.
  • Adequate organ function, including the following:
  • hepatic: total bilirubin ≤ 2 times the upper limit of normal (excluding patients with Gilbert syndrome), aspartate aminotransferase and alanine aminotransferase ≤ 5 times the upper limit of normal,
  • renal: serum creatinine ≤ 2 times the upper limit of normal,
  • bone marrow: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100000/mm3, hemoglobin ≥ 9.5 g/dl.
  • Normal thyroid function (natural or with supplementation of thyroid hormones) defined as thyroid-stimulating hormone within limits of normal.
  • Age eighteen years or older on the day of consent.
  • Written informed consent prior to study entry.

Who cannot join

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Prior systemic pharmacotherapy of RCC.
  • Treatment with propranolol within 6 months of study entry.
  • Metastases in central nervous system (patients who had central nervous system metastases that were surgically resected and/or treated with radiotherapy in the past and now are without neurological symptoms, are allowed on protocol).
  • Female patients who are pregnant or breast feeding or adults of reproductive potential who are not using effective birth control methods.
  • Presence of other malignancies (patients with carcinoma in situ of the cervix or basal cell carcinoma of the skin are allowed on protocol).
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  • Presence of any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • heart failure of New York Heart Association Class III or IV, significant cardiac arrhythmia or any other clinically significant cardiovascular disease,
  • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of entering the study,
  • severely impaired respiration as defined as O2 saturation that is ≤ 90% at rest on room air,
  • uncontrolled diabetes as defined by fasting serum glucose > 1.5 times the upper limit of normal,
  • ejection fraction less than 40% (measured at echocardiography),
  • significant liver disease such as cirrhosis, active hepatitis or chronic persistent hepatitis,
  • active (acute or chronic) infections requiring antimicrobial intervention.
  • Concomitant treatment with:
  • chronic, systemic corticosteroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed,
  • strong CYP3A4 inducers/inhibitors: carbamazepine, phenytoin, rifabutin, rifampin, nafcillin, phenobarbital, St John's wort, itraconazole, ketoconazole, erythromycin, clarithromycin, nefazodone.
  • Known allergy/sensitivity to sunitinib and/or propranolol.
  • Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • Immunization with attenuated live vaccines within 30 days of study entry.
  • Human immunodeficiency virus sero-positivity at the study entry or in the past.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sunitinib and/or propranolol (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
  • Presence of active, bleeding diathesis.
  • Major surgery (defined as requiring general anesthesia) and/or significant traumatic injury (requiring > 28 days to heal) within 28 days of the study entry; presence of side effects due to any surgery or probable requirement of major surgery during the course of the study.
  • Present contraindications to propranolol, that include: bronchial asthma, prolonged fasting, acidosis, hypotension (systolic blood pressure less than 90 mmHg, diastolic blood pressure less than 60 mmHg), severe peripheral arterial circulatory disturbance, cardiogenic shock, bradycardia, Prinzmetal's angina, uncontrolled heart failure, second or third degree heart block, untreated phaeochromocytoma, sick sinus syndrome.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Military Institute of Medicine

    Warsaw, Masovian Voivodeship, 04141

Other trials in Poland

About this study

Official title: A Phase II Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma (ProSun Study)

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

Being tested
Propranolol, Sunitinib
Keywords
Metastatic, Renal Cell Carcinoma, Kidney Cancer, Sunitinib, Sutent, Tyrosine Kinase Inhibitor, Angiogenesis Inhibitor, Propranolol, Beta-blocker, First-line
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropranololDrug

    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).

  • SunitinibDrug

    Also called Sutent

    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.

Study groups in NCT03323710
Study groupRoleWhat they receive
Propranolol plus SunitinibExperimentalNot described
Receives: Drug: Propranolol; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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.

    Measured: Up to 18 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from treatment initiation to death from any cause.

    Measured: Up to 18 months

  2. Progression-free Survival (PFS)

    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.

    Measured: Up to 18 months

  3. Disease Control Rate (DCR)

    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.

    Measured: Up to 18 months

  4. Safety profile as assessed by Common Terminology Criteria for Adverse Events v4.03 summarized by type, frequency, and severity.

    Safety profile as assessed by Common Terminology Criteria for Adverse Events v4.03 summarized by type, frequency, and severity.

    Measured: Up to 18 months

  5. Health-related Quality of Life (QoL)

    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:

    1. Estimate the average of the items that contribute to the scale (the raw score).
    2. 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.

    Measured: Up to 18 months

  6. Health-related Quality of Life (QoL)

    Change from baseline in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - 15.

    Measured: Up to 18 months

  7. Disease-related Stress (DRS)

    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:

    1. Reverse scores for questions 4, 5, 7, and 8.
    2. 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.

    Measured: Up to 18 months

  8. Tumour tissue and serum biomarkers status

    Descriptive statistics of selected biomarkers from analysis of patient samples.

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2017
  2. Study startSep 2018 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Why it stopped: Poor patient recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Two-stage optimal Simon design
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03323710
Sponsor's protocol ID
PS-001
Status last verified
Jan 2019
First submitted
22 Oct 2017
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol and Sunitinib in people with Renal Cell Carcinoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03323710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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