Metastatic Renal Cell CarcinomaPhase 1NCT00625768
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
A Phase 1 study testing AS1409 in people with Metastatic Renal Cell Carcinoma and Metastatic Malignant Melanoma, run by Antisoma Research at 4 sites in 2 countries.
Trial summary
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Metastatic Malignant Melanoma
- What is being tested?
- AS1409
- How many people
- 13 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 1
- 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
- Be 18 years or older at the time of giving informed consent.
- Histologically confirmed diagnosis of renal cell carcinoma or malignant melanoma.
- If renal cell carcinoma, of clear cell or chromophilic/papillary type, with metastases at any site (but excluding patients with single bony lesion only).
- If malignant melanoma, unresectable Stage III disease or Stage IV disease, with metastases at any site (but excluding patients with single bony lesion only)
- Patients with clinically stable CNS metastases may enter who have been treated with surgery or radiation and who do not require steroid therapy.
- ECOG performance status 0-2.
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- Patients who have received prior systemic treatment for their malignancy with chemotherapeutic or biological therapies may enter, provided treatment was completed within 4 weeks of study entry.
- Patients who have received prior experimental therapy may enter, provided treatment was completed within 12 weeks of study entry.
- Have adequate bone marrow function as evidenced by neutrophils >1.5 x109/L and platelets >100 x109/L.
- Have adequate liver and kidney function, as shown by serum bilirubin ≤1.5x upper limit of normal for the laboratory; ALT and AST both ≤2x upper limit of normal; and creatinine ≤1.5x upper limit of normal.
- Have either evaluable or measurable disease (patients entering an ascending dosage cohort) or measurable disease (patients entering the study after MTD is defined).
- Patients who have failed and or are ineligible for standard first line therapy (in accordance with individual institutional practice)
Who cannot join
- Patients with any of the following will be excluded from the study:
- Patients at poor medical risk because of non-malignant systemic disease or active infection.
- History of clinically significant autoimmune or predominantly Th1-driven clinical disorders (such as rheumatoid arthritis, psoriasis, chronic inflammatory bowel disease, for example), with the exception of autoimmune endocrinopathies now treated with replacement therapy.
- Diabetic retinopathy.
- Substantive surgery within 4 weeks prior to study entry, or expectation of surgery during the study period.
- Malignancy other than renal cell carcinoma or malignant melanoma within 5 years of study entry, except for non-melanoma skin cancer and cervical intraepithelial neoplasia treated definitively or other cancer from which the patient has been disease-free for 5 years.
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- Concurrent treatment with systemic steroids or with other immunosuppressive therapies.
- If female, pregnant or breastfeeding;
- Women of child bearing potential or sexually active males, unless (1) the patient (if female, or the patient's partner, if male) is surgically sterile or (2) using adequate contraception (defined as either IUD, oral or depot contraceptive, or barrier plus spermicide) while receiving study treatment and for at least 6 months after termination of treatment. Women must be post-menopausal for at least 2 years to be considered of non-childbearing potential
- Any concurrent medical or psychological condition that would limit the ability of the patient to provide informed consent or to comply with the obligations of the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom2 sites
Guys Hospital
London, SE1 9RT
Charing Cross Hospital
London, W6 8RF
About this study
Official title: A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Read the detailed description
- To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
- To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
- To determine preliminary pharmacokinetics of AS1409.
- To determine the immunogenicity of AS1409
- To explore the anti-tumour activity of AS1409.
- Being tested
- AS1409
- Keywords
- Antibody, safety, tolerability, efficacy, metastatic renal cell carcinoma, metastatic malignant melanoma
- Medical subject headings
- Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1409Drug
Also called huBC1-huIL-12
Study drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor assessment
Measured: 6 weeks, response confirmed at 4 weeks
Biomarkers (interferon-γ and IP-10 Interferon)
Measured: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Adverse event monitoring
Measured: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionApr 2009
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 Metastatic Renal Cell CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Spicer, MD, Principal investigator, Kings College School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625768
- Sponsor's protocol ID
- AS1409-101
- Status last verified
- Aug 2009
- First submitted
- 20 Feb 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rudman SM, Jameson MB, McKeage MJ, Savage P, Jodrell DI, Harries M, Acton G, Erlandsson F, Spicer JF. A phase 1 study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma or renal cell carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1998-2005. doi: 10.1158/1078-0432.CCR-10-2490. Epub 2011 Mar 29.
PubMed 21447719
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00625768
- Acronym / sponsor ID
- AS1409-101
- Keywords
- Antibody, safety, tolerability, efficacy, metastatic renal cell carcinoma, metastatic malignant melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Feb 2008 (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.
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Detailed description
- To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
- To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
- To determine preliminary pharmacokinetics of AS1409.
- To determine the immunogenicity of AS1409
- To explore the anti-tumour activity of AS1409.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be 18 years or older at the time of giving informed consent.
- Histologically confirmed diagnosis of renal cell carcinoma or malignant melanoma.
- If renal cell carcinoma, of clear cell or chromophilic/papillary type, with metastases at any site (but excluding patients with single bony lesion only).
- If malignant melanoma, unresectable Stage III disease or Stage IV disease, with metastases at any site (but excluding patients with single bony lesion only)
- Patients with clinically stable CNS metastases may enter who have been treated with surgery or radiation and who do not require steroid therapy.
Key exclusion criteria (10 listed)
- Patients at poor medical risk because of non-malignant systemic disease or active infection.
- History of clinically significant autoimmune or predominantly Th1-driven clinical disorders (such as rheumatoid arthritis, psoriasis, chronic inflammatory bowel disease, for example), with the exception of autoimmune endocrinopathies now treated with replacement therapy.
- Diabetic retinopathy.
- Substantive surgery within 4 weeks prior to study entry, or expectation of surgery during the study period.
- Malignancy other than renal cell carcinoma or malignant melanoma within 5 years of study entry, except for non-melanoma skin cancer and cervical intraepithelial neoplasia treated definitively or other cancer from which the patient has been disease-free for 5 years.
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 |
|---|---|---|
| AS1409Also: huBC1-huIL-12Study drug | Drug | – |
Primary outcome
Tumor assessment
Time frame: 6 weeks, response confirmed at 4 weeks
Biomarkers (interferon-γ and IP-10 Interferon)
Time frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Adverse event monitoring
Time frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
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 25 Aug 2009.
- Derived from this study: PubMed 21447719Rudman SM, Jameson MB, McKeage MJ, Savage P, Jodrell DI, Harries M, Acton G, Erlandsson F, Spicer JF. A phase 1 study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma or renal cell carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1998-2005. doi: 10.1158/1078-0432.CCR-10-2490. Epub 2011 Mar 29.
- Click here for additional information of Antisoma, the company sponsoring this studyLink provided by the sponsor.
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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.
James Spicer, MD principal investigator
Kings College School of Medicine
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AS1409 in people with Metastatic Renal Cell Carcinoma and Metastatic Malignant Melanoma, run by Antisoma Research at 4 sites in 2 countries.
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 12 inclusion and 10 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 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Tumor assessment (time frame: 6 weeks, response confirmed at 4 weeks). The study lists 3 primary outcomes in all. 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 NCT00625768, 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 25 Aug 2009.