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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 : Available
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
ArQule

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

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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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317366


Contacts
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Contact: ArQule, Inc. +1 781-994-0300 ClinicalTrials@arqule.com

Sponsors and Collaborators
ArQule

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Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT03317366     History of Changes
Other Study ID Numbers: ARQ 092 Expanded Access
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by ArQule:
ARQ 092
ArQule
AKT
PIK3CA
Overgrowth
Congenital malformations

Additional relevant MeSH terms:
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Growth Disorders
Vascular Malformations
Proteus Syndrome
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Hamartoma Syndrome, Multiple
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Abnormalities, Multiple