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LBH581

Phase 2

Small Cell Lung Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Oct 18, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

LBH581 · 1 trial · 1 indication

Phase 2 1
NCT01222936LBH Phase II in Small Cell Lung Cancer (SCLC)Small Cell Lung Carcinoma
COMPLETED21 Analytics
PHASE2COMPLETED
LBH Phase II in Small Cell Lung Cancer (SCLC)
Small Cell Lung CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response rate
12-18 weeks (foreseen participation of the patient in the study)

Objective response rate measured according to the RECIST (Response Evaluation Criteria In Solid Tumours).

Secondary Endpoints

Duration of antitumor activity
12-18 weeks (foreseen participation of the patient in the study)
Drug safety profile
28 days following the last dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
LBH581DRUG25 mg/5 ml solution packaged in 6 ml type I glass vials and given as a 30 minutes infusion at the dose of 20 mg/m2 i.v., on day 1 and 8, every 21 days.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Histological/cytological diagnosis of SCLC, mixed small and non small cell tumours are excluded 2. ≤ 2 prior chemotherapy lines 3. Progression after, and not during, last previous chemotherapy treatment 4. Age ≥ 18 and ≤ 75 years 5. Life expectancy of at least 3 months 6. ECO...

Countries:GermanyItaly
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Frequently asked questions about LBH581

What is LBH581 used for?

LBH581 is an investigational small molecule being studied for the treatment of Small Cell Lung Carcinoma. It is in Phase 2 clinical development and has completed one trial in this indication. The drug is not approved and remains under investigation.

Who makes LBH581?

LBH581 is being developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Small Cell Lung Carcinoma.

What phase is LBH581 in?

LBH581 is in Phase 2 clinical development. A Phase 2 trial in Small Cell Lung Carcinoma has been completed. The drug is investigational and has not received regulatory approval for any use.

What clinical trials is LBH581 in?

LBH581 has been studied in one clinical trial, identified as NCT01222936, titled 'LBH Phase II in Small Cell Lung Cancer (SCLC)'. This Phase 2 study enrolled 21 participants and was conducted in Germany and Italy. The trial has been completed.

Is LBH581 the same as LBH?

LBH581 is the drug name used in the clinical trial NCT01222936, which is titled 'LBH Phase II in Small Cell Lung Cancer (SCLC)'. The trial refers to the drug as LBH, indicating that LBH581 and LBH are alternative names for the same investigational compound.