Clinical Trials Logo
  1. Home
  2. Growth Disorders
  3. NCT03317366
  4. Details
NCT03317366 Clinical Trial

Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies

Growth Disorders Clinical Trial

Official title:
Expanded Access to Provide ARQ 092 for the Treatment of Overgrowth Diseases and/or Vascular Anomalies With Genetic Alterations of the PI3K/AKT Pathway

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03317366
Other study ID # ARQ 092 Expanded Access
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date July 2021
Source ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

ARQ 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the PI3K/AKT pathway and may be available for patients who are ineligible for an ongoing ARQ 092 clinical trial or have other considerations that prevent access to ARQ 092 through an existing clinical trial.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: 1. Severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of PIK3CA or AKT 2. Are unable to participate in an ongoing ARQ 092 clinical trial 3. Willing and able to provide written, signed informed consent. In the case of a minor, a parent or legal guardian must sign an informed consent form. 4. Medically suitable for treatment with ARQ 092 5. Not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of PIK3CA or AKT Exclusion Criteria: 1. Currently enrolled in an ongoing clinical study of ARQ 092 or other investigational drug 2. Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ARQ 092
Open-label expanded access for ARQ 092 capsules

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
See also
  Status Clinical Trial Phase
Completed NCT01376921 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain N/A
Completed NCT01400997 - Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic N/A
Completed NCT05244785 - Health and Nutrition Survey on Shenzhen Children
Completed NCT00097539 - A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin Phase 4
Not yet recruiting NCT04576845 - The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Not yet recruiting NCT05056285 - Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
Completed NCT01263457 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
Terminated NCT00330668 - Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency Phase 3
Completed NCT00378859 - The Effect of Milk and Meat on IGFs in Prepubertal Boys N/A
Not yet recruiting NCT05577130 - Growth Pattern and Characteristics of Cardiac Pediatric Patients
Recruiting NCT05033119 - PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Completed NCT01402999 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary N/A
Completed NCT01267526 - A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment N/A
Completed NCT00139451 - Nutrients and Hormones: Effects in Boys With Disordered Growth Phase 2
Terminated NCT03274973 - Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
Completed NCT02015286 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East N/A
Completed NCT01582334 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina N/A
Completed NCT01439061 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy N/A
Completed NCT00125164 - Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency Phase 3
Completed NCT00174408 - Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age Phase 3