Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00625768




Registration number
NCT00625768
Ethics application status
Date submitted
20/02/2008
Date registered
28/02/2008
Date last updated
25/08/2009

Titles & IDs
Public title
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
Scientific title
A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
Secondary ID [1] 0 0
AS1409-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma 0 0
Metastatic Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AS1409

Treatment: Drugs: AS1409
Study drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumor assessment
Timepoint [1] 0 0
6 weeks, response confirmed at 4 weeks
Primary outcome [2] 0 0
Biomarkers (interferon-? and IP-10 Interferon)
Timepoint [2] 0 0
Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose
Primary outcome [3] 0 0
Adverse event monitoring
Timepoint [3] 0 0
Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Antisoma Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of
AS1409 in single and repeated doses.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00625768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Spicer, MD
Address 0 0
Kings College School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00625768