This study will evaluate the efficacy and safety of alectinib in patients with Anaplastic Lymphoma Kinase (ALK)-positive locally-advanced or metastatic solid tumors other than lung cancer and Cancer of Unknown Primary (CUP).

NCT04644315

Conditions

1. Solid Tumors

Interventions

1. Drug: Alectinib

MeSH:Neoplasms

HPO:Neoplasm

Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) 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 V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) 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 those described in the protocol - 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 any of the ingredients in the alectinib drug formulation Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) 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 V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) 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 those described in the protocol - 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 any of the ingredients in the alectinib drug formulation Solid Tumors Neoplasms null --- G1202R --- --- V1180L ---

Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) 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 V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) 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 those described in the protocol - 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 any of the ingredients in the alectinib drug formulation Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) 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 V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) 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 those described in the protocol - 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 any of the ingredients in the alectinib drug formulation Solid Tumors Neoplasms null --- G1202R --- --- V1180L --- --- G1202R --- --- V1180L ---