Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

Novartis

Status and phase: Completed; Phase 1

Conditions: Uterine Leiomyoma; Castration-resistant Prostate Cancer; Metastatic Breast Cancer

Treatments: Drug: LFA102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338831

2011-000494-32 (EudraCT Number)

CLFA102X2102

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 4 patient groups

Breast & Prostate Cancer Group

Experimental group

Description:

Dose Escalation

Treatment:

Drug: LFA102

Breast Cancer Group

Experimental group

Description:

Dose Expansion

Treatment:

Drug: LFA102

Prostate Cancer Group

Experimental group

Description:

Dose Expansion

Treatment:

Drug: LFA102

Uterine Leiomyoma Group

Experimental group

Description:

Dose Expansion

Treatment:

Drug: LFA102