Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Metastatic, Prostate Cancer
NCT ID: NCT01338831
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-324
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
Michaela Higgins,
Massachusetts General Hospital
Site-responsible Investigators:
Sara Tolaney, MD,
Dana-Farber Cancer Institute
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed diagnosis of prostate or breast adenocarcinoma
2. Detectable metastases by bone scan, CT-scan, or MRI.
3. Presence of prolactin receptor in primary or metastatic tumor
4. Suitable venous access for blood sampling
Exclusion Criteria:
1. Prior treatment with any anti-prolactin receptor antibody
2. Major surgery within 28 days before study treatment
3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
4. Prior anaphylactic or other severe infusion reaction to antibody formulations
Other protocol-defined inclusion/exclusion criteria may apply