A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
Condition: Neoplasms; Colorectal Neoplasms; Melanoma; Pancreatic Neoplasms; Sarcoma; Ovarian Neoplasms; Brain Neoplasms; Thyroid Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Salivary Gland Neoplasms; Head and Neck Neoplasms; Thyroid Cancer, Papillary; Lymphoma, Large-Cell, Anaplastic; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Central Nervous System
MeSH terms: Neoplasms; Melanoma; Sarcoma; Thyroid Neoplasms; Cholangiocarcinoma; Neuroendocrine Tumors; Colorectal Neoplasms; Pancreatic Neoplasms; Head and Neck Neoplasms; Ovarian Neoplasms; Brain Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Thoracic Neoplasms; Intestinal Neoplasms; Respiratory Tract Neoplasms; Bronchial Neoplasms; Carcinoma, Bronchogenic; Lymphoma, Large-Cell, Anaplastic; Thyroid Cancer, Papillary; Salivary Gland Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Diseases; Thyroid Diseases
Intervention: Alectinib
Intervention description: Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: agnostic; ALK+; Alk-positive; ALK positive; ALK mutation; GI; breast; sarcoma; neuroendocrine; female reproductive; ALK; ALK fusions; ALK gene rearrangements; colorectal cancer; entrectinib; basket study; salivary gland cancers; primary brain tumors; melanoma; sarcomas; papillary thyroid cancer; renal cell cancer; pancreatic cancer; breast cancer; cholangiocarcinoma; head & neck cancers; ovarian cancer; anaplastic lymphoma kinase positive; solid tumors; ALK+ solid tumors

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.
    

Eligibility criteria:

        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 dose of study drug

          -  Women of childbearing potential must agree to remain abstinent or use contraceptive
             methods as defined by the protocol and refrain from donating eggs during the treatment
             period and for at least 90 days after the last dose of alectinib

          -  Men must agree to remain abstinent or use contraceptive methods as defined by the
             protocol and refrain from donating sperm during the treatment period and for at least
             90 days after the last dose of alectinib

        Exclusion Criteria:

          -  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 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 for 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