Kidney CancerPhase 3NCT00005995
AE-941 in Treating Patients With Metastatic Kidney Cancer
A Phase 3 study testing shark cartilage extract AE-941 in people with Kidney Cancer, run by AEterna Zentaris at 1 site in Canada.
Trial summary
RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- shark cartilage extract AE-941
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Oct 2000to Mar 2007
- 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
DISEASE CHARACTERISTICS: Histologically confirmed renal cell adenocarcinoma Disease progression within 16 weeks after first-line therapy, which included interleukin-2 and/or interferon Metastatic disease not amenable to surgery Measurable and/or evaluable disease No more than one line of prior anticancer treatment for renal cell carcinoma No pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumor No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at least 2,500/mm3 Hemoglobin at least 8 g/dL (epoetin alfa allowed) Hepatic: Not specified Renal: Calcium no greater than the upper limit of normal (ULN) (bisphosphonates allowed) Creatinine no greater than 2 times ULN Other: No other prior malignancy within past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix No severe allergy to fish or seafood No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection) No significant medical or psychiatric condition that would preclude study Not pregnant Negative pregnancy test Fertile patients must use adequate contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month but no longer than 8 months since prior immunotherapy Chemotherapy: Not specified Endocrine therapy: At least 1 week since prior systemic corticosteroids for symptomatic treatment of renal cell carcinoma At least 28 days since prior medroxyprogesterone acetate No concurrent medroxyprogesterone acetate Concurrent corticosteroids for symptomatic treatment of neurological complications caused by renal cancer allowed Radiotherapy: Concurrent radiotherapy to symptomatic lesions for symptom relief allowed Surgery: See Disease Characteristics Concurrent surgical removal of symptomatic lesions for symptom relief allowed Other: At least 28 days since other prior experimental therapeutic agents At least 28 days since other prior shark cartilage products No other concurrent therapies for metastatic renal cell carcinoma No other concurrent shark cartilage products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy
RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy.
Read the detailed description
OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory to immunotherapy treated with AE-941 (Neovastat) versus placebo. II. Compare the time to progression and one-year survival rate of patients treated with this regimen. III. Determine the safety of this regimen in these patients. IV. Compare the overall tumor response rate, duration of response, and quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to number of organs with metastases (1 vs more than 1) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral AE-941 (Neovastat) twice a day. Arm II: Patients receive oral placebo twice a day. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter. Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.
- Conditions
- Kidney Cancer
- Being tested
- shark cartilage extract AE-941
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shark cartilage extract AE-941Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startOct 2000
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005995
- Sponsor's protocol ID
- CDR0000067999
- Other IDs
- AETERNA-AE-RC-99-02, CAN-CCI-ETH-00-32-17, CCF-IRB-3664, JGH-00023, UCMC-0006305, UPCC-2800
- Status last verified
- Feb 2008
- First submitted
- 5 Jul 2000
- Last updated
- 5 Mar 2013
- Results posted
- No
Publications
Escudier B, Choueiri TK, Oudard S, Szczylik C, Negrier S, Ravaud A, Chevreau C, Venner P, Champagne P, Croteau D, Dupont E, Hariton C, Bukowski RM. Prognostic factors of metastatic renal cell carcinoma after failure of immunotherapy: new paradigm from a large phase III trial with shark cartilage extract AE 941. J Urol. 2007 Nov;178(5):1901-5. doi: 10.1016/j.juro.2007.07.035. Epub 2007 Sep 17.
PubMed 17868728
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy
- ClinicalTrials.gov ID
- NCT00005995
- Acronym / sponsor ID
- CDR0000067999
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Mar 2007 (actual)
- First posted
- 12 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: AE-941 may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase III trial to determine the effectiveness of AE-941 in treating patients who have metastatic kidney cancer that has not responded to biological therapy.
Detailed description
OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory to immunotherapy treated with AE-941 (Neovastat) versus placebo. II. Compare the time to progression and one-year survival rate of patients treated with this regimen. III. Determine the safety of this regimen in these patients. IV. Compare the overall tumor response rate, duration of response, and quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to number of organs with metastases (1 vs more than 1) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral AE-941 (Neovastat) twice a day. Arm II: Patients receive oral placebo twice a day. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter. Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shark cartilage extract AE-941 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Results publication: PubMed 17868728Escudier B, Choueiri TK, Oudard S, Szczylik C, Negrier S, Ravaud A, Chevreau C, Venner P, Champagne P, Croteau D, Dupont E, Hariton C, Bukowski RM. Prognostic factors of metastatic renal cell carcinoma after failure of immunotherapy: new paradigm from a large phase III trial with shark cartilage extract AE 941. J Urol. 2007 Nov;178(5):1901-5. doi: 10.1016/j.juro.2007.07.035. Epub 2007 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing shark cartilage extract AE-941 in people with Kidney Cancer, run by AEterna Zentaris at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Mar 2013. 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 Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005995, which also lists 1 linked publication.
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 5 Mar 2013.