A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced … (NCT04644315) | Clinical Trial Compass
TerminatedPhase 2
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
Stopped: The data from this study is no longer needed.
United States1 participantsStarted 2021-05-24
Plain-language summary
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer
* ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory using validated NGS testing of tumor tissue or peripheral blood
* No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant
* Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade \</= 1 or to laboratory values as defined by the protocol
* Measurable disease at baseline as assessed by the Investigator per RECIST v1.1 or RANO criteria (for participants with primary CNS tumors)
* Life expectancy of at least 12 weeks
* Eastern cooperative oncology group (ECOG) performance status of 0-2
* Adequate hemataologic, hepatic, and renal function
* Participants with primary central nervous system (CNS) tumors are available
* Participants with brain or leptomeningeal metastasis are allowed in the study if asymptomatic and if they meet additional criteria as defined by the protocol
* Willingness to comply with study procedures
* Willingness to comply with home-base approach and visits by Mobile Nurses
* Ability to swallow alectinib capsules intact
* Women of childbearing potential must test negative for pregnancy at screening and prior to the first…
What they're measuring
1
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)