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Renal Cell CarcinomaPhase 3NCT00478114

Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma (RCC)

A Phase 3 study testing sorafenib in people with Renal Cell Carcinoma, run by Mahidol University at 1 site in Thailand.

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

This is the early access programme (EAP) of sorafenib in the indication of advanced renal cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in patients with advanced RCC. 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?
sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteThailand
Study dates
May 2007to Mar 2010
Phase
Phase 3
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

  • Written informed consent prior to receiving sorafenib.
  • At least 18 years of age.
  • Advanced Renal Cell Carcinoma.
  • A patient who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i.e. resolved back to CTC-AE Grade 1 or less).
  • For patients, who have had major surgery or injury, the wound must be completely healed prior to receiving sorafenib treatment (4 weeks).
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men must use adequate birth control for at least 3 months after the last administration of sorafenib. Should a woman become pregnant while participating or while the partner of a patient is participating in the study, they should inform their treating physician immediately.

Who cannot join

  • Pregnant or breastfeeding women.
  • Patients with metastatic brain or meningeal tumours.
  • Cardiac disease: greater than NYHA functional class II; unstable CAD; MI within the last 6 months.
  • HIV infection or chronic hepatitis B or C; patients with Child-Pugh class C hepatic impairment.
  • Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
  • Patients with active uncontrolled hypertension.
Show all 19Show fewer
  • Patients with recent or active bleeding diathesis.
  • Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
  • Excluded therapies or medications, previous and concomitant:
  • Bone marrow transplant or stem cell rescue within 4 months of study entry.
  • Anticipation of the need for major surgery during the course of the study.
  • CYP 3A4 inducers (e.g. rifampicin, St. John's Wort [Hypericum perforatum], phenytoin, phenobarbital and dexamethasone).
  • Any investigational therapy while on this protocol or within 30 days prior to their first dose of sorafenib.
  • Any drugs (licensed or investigational) that targets angiogenesis, especially VEGF or VEGF-Receptors (e.g. bevacizumab).
  • Any drug (licensed or investigational) that targets Ras-pathway or EGFR.
  • Biological response modifiers, such as G-CSF or GM-CSF, within 3 weeks prior to study entry or during study (G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity such as febrile neutropenia, when medically indicated or at the discretion of the Investigator).
  • Use of Megestrol-acetate and medroxyprogesterone.
  • Patients taking narrow therapeutic index medications will be monitored closely.
  • These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital, cyclosporine and digoxin.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Siriraj Hospital, Department of Medicine

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma

This is the early access programme (EAP) of sorafenib in the indication of advanced renal cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in patients with advanced RCC.

Read the detailed description

Renal cell carcinoma (RCC) accounts for approximately 3 % of all cancers. RCC can be cured if diagnosed and treated when still localized to the kidney or immediate surrounding tissues. Since most of the RCC tumours are diagnosed when still localized, approximately 40 % of all patients survive 5 years. The median survival of Stage IV RCC after diagnosis is 8 to 12 months and the 5-year survival is less than 10 %. Surgery has been the primary therapy for RCC for more than a century. Until recently, metastatic disease has been refractory to any systemic therapy. Despite recent advances in immunotherapy (e.g. Interferon and Interleukin-2), the response rates remain low (15 %) and few patients experience durable remission. Surgical and radiation therapies for Stage IV disease are generally limited to palliation of symptoms. For the majority of patients, metastatic RCC is incurable and patients should be considered candidates for clinical trials when appropriate. In summary, the available therapies for advanced unresectable and/or metastatic RCC have limited clinical values, with response rates ranging from 6-20 % and little impact on the natural history of the disease. Furthermore, the toxicities associated with these agents can be severe, requiring careful patient selection, and this dramatically decreases the number of patients who may benefit from therapy. Advanced RCC remains incurable and the need for more effective therapies is high.

This is a non-randomized, open-label treatment protocol for patients with advanced RCC. Patients will be treated with 400 mg oral sorafenib twice a day on a continuous. Patients in this protocol may continue to be treated with sorafenib as a single agent until any of the following criteria for drug or protocol discontinuation is reached:

  1. Progression of disease.
  2. The patient is unlikely to benefit from further treatment with sorafenib as judged by the Investigator.
  3. Intolerable toxicity of the drug.
  4. Withdrawal of consent for any reason.
Being tested
sorafenib
Keywords
Renal Cell Carcinoma, Sorafenib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • sorafenibDrug

    Also called nexavar

    sorafenib in the patients with advanced Renal Cell Carcinoma

Study groups in NCT00478114
Study groupRoleWhat they receive
1ExperimentalSorafenib
Receives: Drug: sorafenib

What is being measured

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

  1. To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC

    Measured: two years

Secondary outcomes (1)

  1. To evaluate the safety (all drug-related adverse events, all adverse events NCI CTCAE 3.0 Grade 3 or higher) of sorafenib in patients with advanced RCC

    Measured: two years

Timeline

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

  1. First posted24 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2009
  4. Study completionMar 2010

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478114
Sponsor's protocol ID
12750
Status last verified
Aug 2011
First submitted
23 May 2007
Last updated
29 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sorafenib in people with Renal Cell Carcinoma, run by Mahidol University at 1 site in Thailand.

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 6 inclusion and 19 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 29 Aug 2011. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC (time frame: two years). 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 NCT00478114.

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 29 Aug 2011.

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