Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2017 |
| Start Date: | September 2011 |
| End Date: | March 2014 |
A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
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.
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.
Inclusion Criteria:
1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine
leiomyoma
2. Detectable metastases by bone scan, CT-scan, or MRI.
3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
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
We found this trial at
6
sites
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Philadelphia, Pennsylvania 19107
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