Castration-resistant Prostate Cancer, Advanced Breast Cancer
Conditions
Keywords
castration-resistant prostate cancer, advanced breast cancer
Brief summary
This study will evaluate safety and tolerability to determine the MTD/RD.
Detailed description
This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure. This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.
Interventions
DRUGLFA102
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of prostate cancer * Histologically or cytologically confirmed locally advanced or metastatic breast cancer
Exclusion criteria
* Patients with untreated and/or symptomatic metastatic CNS disease * Prior anaphylactic or other severe infusion reaction * Treatment with agent which affect prolactin levels * Active autoimmune disease Other protcol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT) | 1st treatment cycle (28 days) | Frequency and severity of dose limiting toxicities (DLTs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration | cycle 1 day 1 until disease progression | — |
| Objective Response Rate | every 8 week or 12 weeks, until disase progression | Assessed based on RECIST/PCWG2 criteria |
| Frequency, duration and severity of Adverse Events (AEs) | at informed consent, until 28 days after treatment discontinuation | Frequency, duration and severity of all AEs will be collected. |
| Progression Free Survival | every 8 or 12 weeks until disease progression | Assessed based on RECIST/PCWG2 criteria |
| PK parameters | cycle 1 day 1 until disease progression | Cmax, Tmax, AUC, T1/2, CL and V |
| Antibodies against LFA102 | day 1 of each treatment cycle until disease progression | Serum concentration of antibodies against LFA102 |
Countries
Japan
Outcome results
None listed