A long term follow up study of ATX-101 given by intravenous infusion once every week in patients with advanced solid tumours.
- Conditions
- Advanced Solid TumorsCancer - Any cancer
- Registration Number
- ACTRN12618001112257
- Lead Sponsor
- Therapim Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
1.Subjects with advanced solid tumours who have completed at least six infusions of ATX-101 in study AM ATX101-01 with no progressive disease based on RECIST V1.1 at the AM ATX101-01 EOS visit.
2.Signed written informed consent.
3.Women of child-bearing potential (WOCBP) must use highly effective contraceptive measures (failure rate of < 1% per year when used consistently and correctly) and intend to continue use of contraception for at least 1 month following the last infusion. Highly effective contraceptive measures could include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, and sexual abstinence
4.Males who are not surgically sterile must use a condom through to study completion and for 30 days after the last treatment administration, unless they have a female partner who is surgically sterile or post-menopausal. They must refrain from fathering a child during this time.
1.Evidence of disease progression according to RECIST V1.1 during AM ATX101-01.
2.Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy except for palliative bone-directed radiotherapy, immune therapy, or cytokine therapy except for erythropoietin) within 21 days or 5x (five times) their half-lives (whichever is shorter) before the first dose of trial treatment.
3.Use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration-resistant prostate cancer (CRPC), who may remain on treatment with luteinizing hormone–releasing hormone agonists or antagonists.
a. Note: Subjects receiving bisphosphonate or denosumab are eligible provided that treatment was initiated more or equal to 14 days before first dose of treatment.
4.Anticipated requirement for surgery or initiation of anti-cancer therapy during the study period.
5.Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (ß-HCG) pregnancy test at screening or at subsequent clinic visits.
6.Unwilling or unable to follow protocol requirements.
7.Inadequate venous access to allow collection of blood samples.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the long term safety of weekly intravenous infusions for a further maximum period of 12 months in subjects with advanced solid tumours who have completed participation in study AM ATX101-02 with no progressive disease at the end of End of Study Visit. The following assessments will be used for this evaluation:<br>- Treatment exposure<br>- Vital signs and ECG<br>- Laboratory parameters (haematology and biochemistry)<br>- Urinalysis<br>- Physical Examination<br>- Concomitant Medication review<br>- Adverse Events (frequency, severity, and duration of treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03)<br><br><br>[Weekly from Baseline (week 1) to Final Follow-Up Visit which should occur 1 week (± 3 days) after the last administered dose of study drug (maximum period of 12 months).]
- Secondary Outcome Measures
Name Time Method Composite outcome to evaluate the maintenance of non-progressive disease status by radiographic (MRI/CT) assessments per RECIST V1.1 after a further maximum ATX-101 treatment period of up to 12 months with determination of:<br>- Progression-free survival (PFS)<br>- Time to progression (TTP)[At the completion of each 4 cycles of treatment i.e. every 3 months (± 14 days) up to a total of 12 months of treatment.];Exploratory plasma biomarker analysis will be conducted as an exploratory pending the availability of qualified/validated assays. Results from the analysis of exploratory biomarker assessment will be reported separately to the final study report.[Following the first administration of ATX-101 in Cycle 1 of treatment and then again at the completion of each 4 cycles of treatment (i.e. every 3 months ± 3 days) for a maximum period of 12 months of treatment.]