Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Mouth and Tooth Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Lymphoma

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Neuroendocrine Tumors

Head and Neck Neoplasms

Sarcoma

Brain Neoplasms

Thyroid Cancer, Papillary

Lymphoma, Large-Cell, Anaplastic

Colorectal Neoplasms

Salivary Gland Neoplasms

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms, Connective and Soft Tissue

Adenocarcinoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenocarcinoma, Papillary

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Lymphosarcoma

Renal Cell Carcinoma

Neuroendocrine Tumor

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Papillary Thyroid Carcinoma

Neuroepithelioma

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Crizotinib

Entrectinib

Protein Kinase Inhibitors

Enzyme Inhibitors

with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.)

Oral entrectinib (RXDX-101)

Clinical Trials

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Assessed by blinded independent central review (BICR) using RECIST v1.1

Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE

Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively

Hoffmann-La Roche

Bronchial Diseases

Amino Acids

Alectinib

Tyrosine Kinase Inhibitors

Tyrosine

Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

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.

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

ALK-positive Solid Tumors

The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.

Age, Continuous

Sex/Gender, Customized

Race/Ethnicity, Customized

Medical Communications

Confirmed ORR was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response.

Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1

DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1

PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1

CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.

Central Nervous System (CNS) ORR by BICR Per RECIST v1.1

CNS DOR was defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

CNS DOR by BICR Per RECIST v1.1

OS was defined as the time from first dose of study drug to death from any cause- and could not be calculated due to an insufficient number of participants with the event.

Overall Survival (OS)

Percentage of Participants With Adverse Events (AEs)

Percentage of Participants With Serious Adverse Events (SAEs)

Plasma concentration data was not collected as the data for one participant was not sufficient.

Plasma Concentration of Alectinib

ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria

DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

OS in Participants With Primary CNS Tumors

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)	NCT02568267	Breast Cancer Cholangiocarcin... Colorectal Canc... Head and Neck N... Lymphoma, Large... Melanoma Neuroendocrine ... Non-Small Cell ... Ovarian Cancer Pancreatic Canc... Papillary Thyro... Primary Brain T... Renal Cell Carc... Sarcomas Salivary Gland ... Adult Solid Tum...	Entrectinib	18 Years -	Hoffmann-La Roche
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors	NCT04644315	Neoplasms Colorectal Neop... Melanoma Pancreatic Neop... Sarcoma Ovarian Neoplas... Brain Neoplasms Thyroid Neoplas... Neuroendocrine ... Cholangiocarcin... Salivary Gland ... Head and Neck N... Thyroid Cancer,... Lymphoma, Large... Neoplasms by Si... Respiratory Tra... Thoracic Neopla... Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise... Central Nervous...	Alectinib	18 Years -	Hoffmann-La Roche
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors	NCT04644315	Neoplasms Colorectal Neop... Melanoma Pancreatic Neop... Sarcoma Ovarian Neoplas... Brain Neoplasms Thyroid Neoplas... Neuroendocrine ... Cholangiocarcin... Salivary Gland ... Head and Neck N... Thyroid Cancer,... Lymphoma, Large... Neoplasms by Si... Respiratory Tra... Thoracic Neopla... Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise... Central Nervous...	Alectinib	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for head & neck cancers