Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
1 other identifier
interventional
13
2 countries
4
Brief Summary
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedAugust 25, 2009
August 1, 2009
1.2 years
February 20, 2008
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Tumor assessment
6 weeks, response confirmed at 4 weeks
Biomarkers (interferon-γ and IP-10 Interferon)
Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Adverse event monitoring
Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Auckland Medical School
Auckland, New Zealand
Waikato DHB
Hamilton, New Zealand
Guys Hospital
London, SE1 9RT, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
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.
PMID: 21447719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Spicer, MD
Kings College School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 28, 2008
Study Start
January 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
August 25, 2009
Record last verified: 2009-08