ClinicalTrials.gg
No longer availableNCT03317366Updated Aug 6, 2021

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

An expanded access record providing ARQ 092 in Proteus Syndrome, PIK3CA-Related Overgrowth Spectrum (PROS) and Growth Disorders, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). No longer available. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (part of Merck & Co., Inc) · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Proteus Syndrome
  • PIK3CA-Related Overgrowth Spectrum (PROS)
  • Growth Disorders

Keywords

  • ARQ 092
  • ArQule
  • AKT
  • PIK3CA
  • Overgrowth
  • Congenital malformations
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In context

Growth Disorders

227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.

Browse Growth Disorders studies →

Lead sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) is the lead sponsor of 32 studies on the registry; none are open to participants now.

First submitted before ArQule, Inc. became part of Merck & Co., Inc.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 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

Exclusion Criteria:

  1. Currently enrolled in an ongoing clinical study of ARQ 092 or other drug
  2. Currently being treated with any inhibitor of the PI3K/AKT/mTOR pathway
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • Open-label expanded access for ARQ 092 capsules

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03317366
Responsible party
Sponsor
First posted
Oct 23, 2017
Last update
Aug 6, 2021
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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