A Study to Evaluate the Efficacy and Safety of Alectinib in Locally Advanced or Metastatic ALK-Positive Solid Tumors
- Conditions
- Anaplastic lymphoma kinase (ALK)-positive solid tumorsMedDRA version: 23.1Level: LLTClassification code 10084713Term: TumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002352-36-SE
- Lead Sponsor
- F. Hoffmann La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
•Age >= 18 years at time of signing Informed Consent Form
•Histologically confirmed locally advanced or metastatic solid tumor excluding lung cancer
•ALK-positive tumor per FMI NGS (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory using validated NGS testing of tumor tissue or peripheral blood
•Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
•Other prior cancer therapies are allowed
•Measurable disease at baseline, as assessed by investigator (by RECIST v1.1, or according to RANO criteria for patients with primary CNS tumors)
•Life expectancy of at least 12 weeks in the opinion of the investigator
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
•Adequate hematologic, hepatic, renal function
•Patients with primary CNS tumors are eligible
•Patients with CUP tumors are eligible
•Patient with brain or leptomeningeal metastasis are allowed in the study if asymptomatic and if they meet the following criteria:
-No neurological signs and clinically stable for at least 2 weeks without corticosteroid treatment for brain metastasis prior to first dose of alectinib
-If previously treated with whole brain radiotherapy or gamma-knife radiosurgery, treatment must have been completed at least 2 weeks prior to first dose of alectinib
•Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
•Willingness to comply with home-based approach and visits by mHCPs
•Ability to swallow alectinib capsules intact (without chewing, crushing, or opening)
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib. Women must refrain from donating eggs during this same period.
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm during the treatment period and for least 90 days after the final dose of alectinib
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
•Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
•Lung cancer
•Patients with one of the following ALK point mutations: I1171X, G1202R, V1180L
•Prior therapy with an ALK inhibitor
•Liver disease characterized by any of the following:
–Impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices
–Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
•Known HIV infection
•Patients with symptomatic bradycardia
•Patients with symptomatic or unstable brain metastasis
•Patients with primary CNS tumors are allowed
•Malabsorption syndrome or any other condition that would interfere with enteral absorption
•Incomplete recovery from any surgery prior to treatment
•Any other malignancies within 5 years prior to enrollment, except any cured cancer that is considered to have no impact on PFS or OS for the current ALK-positive solid tumor
•Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
•History of hypersensitivity to alectinib or any of its excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To demonstrate a clinically relevant response to experimental treatment;Secondary Objective: •To evaluate the efficacy of alectinib in patients with ALK-positive solid tumors in the response evaluable population<br>•To evaluate the safety of alectinib in all dosed patients<br>•To characterize the alectinib pharmacokinetic (PK) profile<br>;Primary end point(s): 1.Confirmed objective response rate (ORR), defined as the proportion of patients with a complete response [CR] or a PR >= 28 days after initial response in patients with solid tumors, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1);Timepoint(s) of evaluation of this end point: 1.Up to 5 years
- Secondary Outcome Measures
Name Time Method