A Phase 1 interventional study of LFA102 in Castration-resistant Prostate Cancer, Advanced Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-11.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
This study will evaluate safety and tolerability to determine the MTD/RD.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 14 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protcol-defined Inclusion/Exclusion criteria may apply.
Drug: LFA102
Also known as: anti prolactin receptor humanized monoclonal antibody
Dose Limiting Toxicities (DLT)
Frequency and severity of dose limiting toxicities (DLTs)
Time frame: 1st treatment cycle (28 days)
Frequency, duration and severity of Adverse Events (AEs)
Frequency, duration and severity of all AEs will be collected.
Time frame: at informed consent, until 28 days after treatment discontinuation
Serum Concentration
Time frame: cycle 1 day 1 until disease progression
Objective Response Rate
Assessed based on RECIST/PCWG2 criteria
Time frame: every 8 week or 12 weeks, until disase progression
Antibodies against LFA102
Serum concentration of antibodies against LFA102
Time frame: day 1 of each treatment cycle until disease progression
Progression Free Survival
Assessed based on RECIST/PCWG2 criteria
Time frame: every 8 or 12 weeks until disease progression
PK parameters
Cmax, Tmax, AUC, T1/2, CL and V
Time frame: cycle 1 day 1 until disease progression
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals