Mobocertinib

Generic Name
Mobocertinib
Brand Names
Exkivity
Drug Type
Small Molecule
Chemical Formula
C32H39N7O4
CAS Number
1847461-43-1
Unique Ingredient Identifier
39HBQ4A67L
Background

Mobocertinib is a kinase inhibitor targeted against human epidermal growth factor receptor (EGFR). It is used specifically in the treatment of non-small cell lung cancer (NSCLC) caused by exon 20 insertion mutations in the EGFR gene, which are typically associated with a poorer prognosis (as compared to "classical" EGFR mutants causing NSCLC) and are associa...

Indication

Mobocertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Associated Conditions
Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Associated Therapies
-

A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-08-14
Last Posted Date
2024-01-08
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
26
Registration Number
NCT04056455
Locations
🇺🇸

Clinical Pharmacology of Miami, Hialeah, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-08-14
Last Posted Date
2023-11-03
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT04056468
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Clinical Pharmacology of Miami, Hialeah, Florida, United States

A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-01-22
Last Posted Date
2024-02-12
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
7
Registration Number
NCT03811834
Locations
🇺🇸

Celerion, Lincoln, Nebraska, United States

A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-01-17
Last Posted Date
2024-03-15
Lead Sponsor
Takeda
Target Recruit Count
53
Registration Number
NCT03807778
Locations
🇯🇵

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

🇯🇵

Hokkaido Cancer Center, Sapporo, Hokkaido, Japan

🇯🇵

Aichi Cancer Center Hospital, Nagoya, Aichi, Japan

and more 22 locations
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