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About
ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).
Enrollment
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Inclusion criteria
Exclusion criteria
Prior investigational therapy within 28 days or at least 5 half-lives before enrolment.
Prior treatment with an agent targeting KRASG12C.
Leptomeningeal disease or untreated brain metastases.
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
Any of the following cardiac abnormalities:
History of stroke or transient ischemic attack within 6 months prior to enrolment.
Ongoing need for treatment with concomitant medication with any of the following characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors that cannot be switched to alternative treatment prior to enrolment.
Known human immunodeficiency virus (HIV) infection.
Acute or chronic hepatitis B or C infection.
Women who are pregnant or in the period of lactation.
Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Primary purpose
Allocation
Interventional model
Masking
68 participants in 1 patient group
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Central trial contact
Heidi Roschitzki, PhD; Susanne Roux
Data sourced from clinicaltrials.gov
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