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Completed

NCT Number: NCT01338831

Phase I Study of LFA102 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.

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Key information

Conditions

Castration-resistant Prostate Cancer Breast Diseases Breast Neoplasms Connective Tissue Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Breast Cancer Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Leiomyoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
  • Detectable metastases by bone scan, CT-scan, or MRI.
  • Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
  • Suitable venous access for blood sampling

Exclusion criteria

  • Prior treatment with any anti-prolactin receptor antibody
  • Major surgery within 28 days before study treatment
  • Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
  • Prior anaphylactic or other severe infusion reaction to antibody formulations

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

LFA102

Drug

Primary outcomes

  1. Incidence rate of Dose Limiting Toxicity

    Time frame: 4 weeks

Secondary outcomes

  1. LFA102 serum concentration

    Time frame: 6 months

  2. Disease response

    Time frame: every 2 to 3 months

  3. Concentrations of antibodies to LFA102

    Time frame: every month

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2011
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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