EUCTR2017-003424-76-GB
Active, not recruiting
Phase 1
A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CTX-SPL9111 (a cabazitaxel (CTX)-dendrimer conjugate) in patients with advanced solid tumours
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with advanced solid tumours
- Sponsor
- Starpharma Pty Ltd
- Enrollment
- 33
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent form.
- •2\. At least 18 years old.
- •3\. Patients with histologically or cytologically confirmed advanced or
- •metastatic cancer for which no curative therapy exists and who, in the
- •opinion of the investigator, could potentially benefit from treatment with
- •4\. Measurable or evaluable disease per RECIST version 1\.1\., Prostate Cancer
- •Working Group 3 (PCWG3\) consensus guidelines (i.e. prostate cancer
- •patients with bone\-only lesions) or Response Assessment in Neuro\-
- •Oncology working group consensus guidelines (RANO; patients with
- •primary central nervous system malignancy).
Exclusion Criteria
- •1\. Uncontrolled brain metastases or spinal cord compression. Patients who
- •were treated with surgical resection or radiation therapy completing at least
- •4 weeks earlier are eligible if they are neurologically stable and have a follow\-up MRI scan performed within the previous 4 weeks showing no
- •tumour progression.
- •2\. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil
- •count (ANC) \< 1\.5 × 109/L or platelet count \< 100 × 109/L (cannot be post\-
- •transfusion) or haemoglobin \< 10 g/dL (can be post\-transfusion).
- •3\. Serum bilirubin \> upper limit of normal (ULN).
- •4\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •level \> 1\.5 × ULN.
Outcomes
Primary Outcomes
Not specified
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