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Renal Cell CancerPhase 2NCT01189370

Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

A Phase 2 study testing sorafenib in people with Renal Cell Cancer, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Cancer
What is being tested?
sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2008to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Adequate bone marrow, liver and renal function as assessed by the following:
  • Hemoglobin ≥ 9.0 grams per deciliter (g/dl)
  • Absolute neutrophil count (ANC)≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
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  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • and aspartate aminotransferase (AST) ≤ 2.5 times the ULN (≤ 5 x ULN for patients with liver involvement)
  • Creatinine < 1.5 times ULN
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to of treatment.
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  • Ability to understand and willing to sign written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • International normalized ratio (INR) < 1.5 or a prothrombin time/partial prothrombin time (PT/PTT) within normal limits unless receiving anti-coagulation treatment with an agent such as warfarin or heparin. These patients may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
  • Must have histologically or cytologically confirmed renal cell carcinoma that is metastatic (M1). Patients with unresectable primary tumor (but MO) are also eligible.
  • Must have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension. Soft tissue disease that has been radiated in the 2 months prior to registration is not assessable as measurable disease. Soft tissue disease within a prior radiation field must have progressed to be considered assessable. X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration. X-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration.
  • Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery. At least 28 days must have elapsed since surgery and must have recovered from any adverse effects of surgery.
  • May have received 1 prior immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or the combination of IFN/IL2 and only 1 prior biologic agent (sunitinib, bevacizumab, or temsorlimus). Must have progressed during this prior therapy. At least 14 days must have elapsed since the last treatment and must have recovered from any adverse effects of prior therapy. May have received prior radiation therapy. At least 21 days must have elapsed since completion of prior radiation therapy. Must have recovered from all associated toxicities at the time of registration.

Who cannot join

  • Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within past 6 months.
  • Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Patients who have received prior sorafenib are ineligible.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B/C.
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  • Active clinically serious infection > CTCAE Grade 2.
  • Thrombosis or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. Patients with renal or caval thrombosis related to the primary renal tumor would not be excluded and are eligible.
  • Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Any malabsorption problem.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: A Phase II Study of the Efficacy and Tolerability of the Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.

Read the detailed description

In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer.

Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink.

Being tested
sorafenib
Keywords
carcinoma, renal cell, kidney, cancer
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

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

  • sorafenibDrug

    Also called BAY 43-9006, Nexavar®

    Dose Level:

    1. 400mg twice daily, continuous.
    2. 600mg twice daily, days 1-5 of each week.
    3. 800mg twice daily, days 1-5 of each week.
Study groups in NCT01189370
Study groupRoleWhat they receive
Intra-Patient Dose Escalation: SorafenibExperimentalAll patients will receive a starting dose of sorafenib 400 mg by mouth twice daily. At four weeks, all patients who have not experienced Grade 3 or 4 toxicity will undergo dose escalation using a treatment schedule of days 1-5 days of each week. Doses will continue to be escalated every 4 weeks depending on tolerability and tumor response.
Receives: Drug: sorafenib

What is being measured

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

  1. Number of Participants Who Could Tolerate Each Dose Level

    Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Overall Number of Participants That Had Disease Progression on Study

    Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

    Measured: 26 months

Timeline

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

  1. First posted26 Aug 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2015
  4. Study completionApr 2015

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
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01189370
Sponsor's protocol ID
11277
Status last verified
Apr 2017
First submitted
25 Aug 2010
Last updated
1 Jun 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib in people with Renal Cell Cancer, run by University of Kansas Medical Center at 1 site in United States.

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 17 inclusion and 17 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: finished, as of the sponsor's last update on 1 Jun 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Could Tolerate Each Dose Level (time frame: 12 weeks). 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 NCT01189370.

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 1 Jun 2017.

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