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ASA404

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 9, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

ASA404 · 1 trial · 1 indication

Phase 1 1
NCT00674102An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety profile and tolerability of ASA404 when administered in combination with paclitaxel and carboplatin in Japanese patients with non small cell lung cancer
First cycle

Secondary Endpoints

To characterize the pharmacokinetics profile of ASA404 in Japanese patients
every 2 cycles
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ASA404EXPERIMENTAL -

Interventions

NameTypeDescription
ASA404DRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: 1. Histologically or cytologically confirmed non-small cell carcinoma of the lung. 2. Newly diagnosed Stage IIIb disease or Stage IV disease 3. No prior treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Note: Prior neoadjuvant or adjuvant chemotherapy within 6 mo...

Countries:Japan
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about ASA404

What is ASA404 used for in Non-small Cell Lung Cancer?

ASA404 is an investigational small molecule being studied for the treatment of Non-small Cell Lung Cancer (NSCLC). It is administered intravenously in combination with paclitaxel and carboplatin. As of the available data, ASA404 is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ASA404?

ASA404 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational oncology small molecule, and its development is currently in the early clinical stage.

What phase is ASA404 in?

ASA404 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The Phase 1 trial for ASA404 has been completed, and the drug remains under investigation for Non-small Cell Lung Cancer.

What clinical trials is ASA404 in?

ASA404 has one completed clinical trial, registered as NCT00674102. This was an open-label, Phase 1 trial that evaluated intravenous ASA404 in combination with paclitaxel and carboplatin in Japanese patients with Non-small Cell Lung Cancer. The trial enrolled 15 participants and was conducted in Japan.

Is ASA404 FDA approved?

ASA404 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Non-small Cell Lung Cancer. The available data shows one completed Phase 1 trial, but no approval status has been established, and the drug remains under clinical investigation.