Study of Infigratinib in Children With Achondroplasia

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 10, 2020

Primary Completion Date

October 21, 2024

Study Completion Date

October 21, 2024

Conditions
Achondroplasia
Interventions
DRUG

Infigratinib 0.016 mg/kg

"Initial cohort dose of infigratinib at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.~Infigratinib tablets to be administered by mouth."

DRUG

Infigratinib 0.032 mg/kg

"Subsequent cohort dose escalation based on protocol-specific criteria.~Infigratinib tablets to be administered by mouth."

DRUG

Infigratinib 0.064 mg/kg

"Subsequent cohort dose escalation based on protocol-specific criteria.~Infigratinib tablets to be administered by mouth."

DRUG

Infigratinib 0.128 mg/kg

"Subsequent cohort dose escalation based on protocol-specific criteria.~Infigratinib tablets to be administered by mouth."

DRUG

Infigratinib 0.25 mg/kg

"Subsequent cohort dose escalation based on protocol-specific criteria.~Infigratinib tablets to be administered by mouth."

Trial Locations (19)

3052

Murdoch Children's Hospital, Parkville

19803

Nemours Alfred I. Dupont Hospital for Children, Wilmington

21211

Johns Hopkins School of Medicine, Baltimore

24086

Hospital Universitario La Paz, Madrid

37232

Vanderbilt University Medical Center, Nashville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

94618

UCSF Benioff Children's Hospital, Oakland

T6G 2H7

Stollery Children's Hospital, Edmonton

Unknown

Hopital Femme Mere Enfant, Lyon

Hopital Necker-Enfants Malades, Paris

Hopital des Enfants, Toulouse

Hospital Universitario Virgen de la Victoria, Málaga

Birmingham Children's Hospital, Birmingham

Queen Elizabeth University Hospital, Glasgow

Evelina London Children's Hospital, London

Manchester University Children's Hospital, Manchester

01012

Vithas Hospital San José, Vitoria-Gasteiz

S10 2TH

Sheffield Children's Hospital, Sheffield

BS1 3NU

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

All Listed Sponsors
lead

QED Therapeutics, Inc., a Bridgebio company

INDUSTRY

NCT04265651 - Study of Infigratinib in Children With Achondroplasia | Biotech Hunter | Biotech Hunter