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LFA102

Phase 1

Castration-resistant Prostate Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

LFA102 · 2 trials · 4 indications

Phase 1 2
NCT01610050A Phase I Study of LFA102 in Japanese PatientsCastration-resistant Prostate Cancer, Advanced Breast Cancer
COMPLETED14 Analytics
NCT01338831Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast CancerCastration-resistant Prostate Cancer
COMPLETED73 Analytics
PHASE1COMPLETED
A Phase I Study of LFA102 in Japanese Patients
Castration-resistant Prostate Cancer, Advanced Breast CancerUnlock trial analytics
PHASE1COMPLETED
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
Castration-resistant Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicities (DLT)
1st treatment cycle (28 days)

Frequency and severity of dose limiting toxicities (DLTs)

Incidence rate of Dose Limiting Toxicity
4 weeks

Secondary Endpoints

Frequency, duration and severity of Adverse Events (AEs)
at informed consent, until 28 days after treatment discontinuation
Serum Concentration
cycle 1 day 1 until disease progression
Objective Response Rate
every 8 week or 12 weeks, until disase progression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LFA102EXPERIMENTAL -
Breast & Prostate Cancer GroupEXPERIMENTALDose Escalation
Breast Cancer GroupEXPERIMENTALDose Expansion
Prostate Cancer GroupEXPERIMENTALDose Expansion
Uterine Leiomyoma GroupEXPERIMENTALDose Expansion

Interventions

NameTypeDescription
LFA102DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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 infusio...

Countries:JapanUnited StatesBelgiumItalySpain
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Frequently asked questions about LFA102

What is LFA102 used for?

LFA102 is an investigational small molecule being studied for the treatment of castration-resistant prostate cancer and advanced or metastatic breast cancer. It has been evaluated in Phase 1 clinical trials in patients with prolactin receptor-positive tumors, including castration-resistant prostate cancer and metastatic breast cancer.

Who makes LFA102?

LFA102 is being developed by Novartis AG, a global pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company has sponsored Phase 1 clinical trials to evaluate the safety and efficacy of LFA102 in oncology indications.

What phase is LFA102 in?

LFA102 is in Phase 1 clinical development. It has completed Phase 1 trials, including a study in patients with prolactin receptor-positive castration-resistant prostate cancer or metastatic breast cancer, and a separate Phase 1 study in Japanese patients. LFA102 is investigational and not yet approved.

What clinical trials is LFA102 in?

LFA102 has been studied in two completed Phase 1 clinical trials. The first, NCT01338831, enrolled 73 patients with prolactin receptor-positive castration-resistant prostate cancer or metastatic breast cancer. The second, NCT01610050, enrolled 14 Japanese patients with castration-resistant prostate cancer or advanced breast cancer.

What does LFA102 target?

LFA102 targets the prolactin receptor, as indicated by its clinical trials which enrolled patients with prolactin receptor-positive tumors. The drug is being studied in oncology indications including castration-resistant prostate cancer and advanced or metastatic breast cancer, where prolactin receptor expression is relevant.

Is LFA102 the same as any other drug?

LFA102 is not known to have alternative names. It is a distinct investigational small molecule developed by Novartis AG. In clinical trials, it is referred to solely as LFA102, and no other names or aliases have been associated with this drug candidate.