Clinical trial · Interventional
A Phase I Study of LFA102 in Japanese Patients
A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
NCT01610050CI-TRIAL-00016034completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate safety and tolerability to determine the MTD/RD.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer, Advanced Breast Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LFA102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LFA102
- interventionNames
- Drug: LFA102
Primary outcomes (1)
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
- 1st treatment cycle (28 days)
- description
- Frequency and severity of dose limiting toxicities (DLTs)
Secondary outcomes (6)
- measure
- Frequency, duration and severity of Adverse Events (AEs)
- timeFrame
- at informed consent, until 28 days after treatment discontinuation
- description
- Frequency, duration and severity of all AEs will be collected.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.