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LA-EP2006

Phase 3

Chemotherapy-induced Neutropenia | Small molecule | Oncology |Novartis AG|Last Updated: Aug 30, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment308

FDA Designations

No designations recorded

Clinical trial landscape

LA-EP2006 · 2 trials · 5 indications

Phase 3 2
NCT01735175Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®Neutropenic Complications
COMPLETED316 Analytics
NCT01516736Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-FilgrastimChemotherapy-induced Neutropenia
COMPLETED308 Analytics
PHASE3COMPLETED
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
Neutropenic ComplicationsUnlock trial analytics
PHASE3COMPLETED
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Chemotherapy-induced NeutropeniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
21 days (Cycle 1 of chemotherapy treatment)

Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9 cells/L (grade 4 neutropenia).

Secondary Endpoints

Incidence of Febrile Neutropenia (FN)
across all cycles (18 weeks)
Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles
across al cycles (18 weeks)
Depth of ANC Nadir in Cycle 1
Cycle 1 (3 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Neulasta®ACTIVE_COMPARATORDuring each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
LA-EP2006EXPERIMENTALDuring each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

Interventions

NameTypeDescription
LA-EP2006DRUGEligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Neulasta®DRUGEligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * histologically proven breast cancer * eligible for six cycles of neoadjuvant or adjuvant chemotherapy Exclusion Criteria: * concurrent or prior chemotherapy for breast cancer * concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunothera...

Countries:BrazilIndiaMexicoRomaniaRussiaUkraineUnited StatesArgentinaChileMalaysiaPuerto RicoSpain
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Frequently asked questions about LA-EP2006

What is LA-EP2006 used for?

LA-EP2006 is an investigational small molecule being developed for chemotherapy-induced neutropenia and neutropenic complications in oncology. It is studied in patients receiving chemotherapy, particularly those with breast cancer, to compare its efficacy and safety against peg-filgrastim.

Who makes LA-EP2006?

LA-EP2006 is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating chemotherapy-induced neutropenia.

What phase is LA-EP2006 in?

LA-EP2006 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed to assess its efficacy and safety compared to peg-filgrastim.

What clinical trials is LA-EP2006 in?

LA-EP2006 has been studied in two completed Phase 3 trials: NCT01516736 and NCT01735175. Both trials compared LA-EP2006 with peg-filgrastim in female patients with breast cancer undergoing chemotherapy, with enrollment of 308 and 316 participants respectively.

How does LA-EP2006 work?

LA-EP2006 is a small molecule designed to address chemotherapy-induced neutropenia. Its specific molecular target is not disclosed in available information, but it is being compared to peg-filgrastim, a granulocyte colony-stimulating factor, in clinical trials.

Is LA-EP2006 the same as peg-filgrastim?

LA-EP2006 is not the same as peg-filgrastim. It is being studied as a potential alternative to peg-filgrastim in Phase 3 trials. The trials are designed to compare the efficacy and safety of LA-EP2006 against peg-filgrastim in treating chemotherapy-induced neutropenia.