Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625768
• Other study ID #: AS1409-101
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2008
• Last updated: August 24, 2009
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Melanoma
• Metastatic Malignant Melanoma
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• AS1409
Study drug

Locations

Country	Name	City	State
New Zealand	Auckland Medical School	Auckland
New Zealand	Waikato DHB	Hamilton
United Kingdom	Charing Cross Hospital	London
United Kingdom	Guys Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor assessment		6 weeks, response confirmed at 4 weeks	No
Primary	Biomarkers (interferon-? and IP-10 Interferon)		Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose	No
Primary	Adverse event monitoring		Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose	Yes