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

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ClinicalTrials.gov Identifier: NCT03317366
Expanded Access Status : No longer available
First Posted : October 23, 2017
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Proteus Syndrome PIK3CA-Related Overgrowth Spectrum (PROS) Growth Disorders Drug: ARQ 092

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: ARQ 092
    Open-label expanded access for ARQ 092 capsules
Eligibility Criteria
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Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
ClinicalTrials.gov Identifier: NCT03317366    
Other Study ID Numbers: ARQ 092 Expanded Access
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021
Keywords provided by ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.):
ARQ 092
ArQule
AKT
 PIK3CA
Overgrowth
Congenital malformations
Additional relevant MeSH terms:
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Proteus Syndrome
Vascular Malformations
Growth Disorders
Congenital Abnormalities
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Hamartoma Syndrome, Multiple
Hamartoma
 Neoplasms
Neoplasms, Multiple Primary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Abnormalities, Multiple