Oncologie, solide tumoren locally advanced or metastatic solid tumors
Conditions
Interventions
The Treatment per Cohort is based on Genetic properties of the tumor
Cohort A - Etrectinib - ROS1 fusion-positive tumors
Cohort B - Etrectinib - NTRK1/2/3 fusion-positive tumors
Cohort C - Alecitnib
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • For patients whose biomarker status is unknown and/or for patients with an ineligible local NGS test result: Signed Biomarker Eligibility Testing Informed Consent Form and willingness to participate in an assigned cohort based on their identified oncogenic biomarker(s) • For patients with a positive biomarker status: Signed cohort-specific Informed Consent Form. • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC) • Performance status as follows: o Patients aged =>18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 • For patients aged => 18: adequate hematologic and end-organ function • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment • Adequate recovery from most recent systemic or local treatment for cancer • Life expectancy => 8 weeks • Ability to comply with the study protocol, in the investigator's judgment • For female patients of childbearing potential: Negative serum pregnancy test =
Exclusion criteria
Exclusion criteria: • Current participation or enrollment in another therapeutic clinical trial • Any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) prior to start of study treatment • Whole brain radiotherapy within 14 days prior to start of study treatment • Stereotactic radiosurgery within 7 days prior to start of study treatment • Pregnant or breastfeeding, or intending to become pregnant during the study • History of or concurrent 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 or confounds the ability to interpret data from the study • Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy Each cohort will also have individual molecule specific inclusion/exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives in this study are divided in efficacy and safety. I Would like to refer to section 'objectives and endpoints', section 2. of the BO41932 (TAPISTRY) Protocol | — |
Countries
Netherlands
Outcome results
None listed