Not provided
Not provided
Not provided
Not provided
The data from this study is no longer needed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK-positive Solid Tumors | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1 | 0 days | |
| Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1 | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science 37, Inc | Culver City | California | 90230 | United States | ||
| Science 37-Basem; Dept 004- Basem |
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ALK-positive Solid Tumors | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2021 | Apr 21, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1 | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) |
| Central Nervous System (CNS) ORR by BICR Per RECIST v1.1 | Baseline up to 5 years |
| CNS DOR by BICR Per RECIST v1.1 | From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years) |
| Overall Survival (OS) | From the first dose of study drug to death from any cause (up to 5 years) |
| Percentage of Participants With Adverse Events (AEs) | Approximately 1 year |
| Percentage of Participants With Serious Adverse Events (SAEs) | Approximately 1 year |
| Plasma Concentration of Alectinib | Baseline up to 5 years |
| ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria | Up to 5 years |
| DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) |
| PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) |
| OS in Participants With Primary CNS Tumors | From the first dose of study drug to death from any cause (up to 5 years) |
| Culver City |
| California |
| 90230 |
| United States |
| Science 37-Beg; Dept 001 Dr. M. Beg | Culver City | California | 90230 | United States |
| Science 37-Cannon; Dept 002-Cannon | Culver City | California | 90230 | United States |
| Science 37-Kurzrock; Dept 005-Kurzrock | Culver City | California | 90230 | United States |
| Science 37-Thomas; Dept 006-Thomas | Culver City | California | 90230 | United States |
| Homebased Telemedicine | Los Angeles | California | 90013 | United States |
| Homebased Telemedicine | Sacramento | California | 95814 | United States |
| Homebased Telemedicine | San Diego | California | 92101 | United States |
| Homebased Telemedicine | San Francisco | California | 94104 | United States |
| Homebased Telemedicine | San Jose | California | 95110 | United States |
| Homebased Telemedicine | Jacksonville | Florida | 32202 | United States |
| Homebased Telemedicine | Miami | Florida | 33132 | United States |
| Homebased Telemedicine | Orlando | Florida | 32801 | United States |
| Homebased Telemedicine | Tampa | Florida | 33601 | United States |
| Homebased Telemedicine | Fort Wayne | Indiana | 46802 | United States |
| Homebased Telemedicine | Indianapolis | Indiana | 46202 | United States |
| Homebased Telemedicine | Minneapolis | Minnesota | 55401 | United States |
| Homebased Telemedicine | Saint Paul | Minnesota | 55155 | United States |
| Homebased Telemedicine | St Louis | Missouri | 63103 | United States |
| Homebased Telemedicine | Buffalo | New York | 14202 | United States |
| Homebased Telemedicine | New York | New York | 10038 | United States |
| Homebased Telemedicine | Philadelphia | Pennsylvania | 19103 | United States |
| Homebased Telemedicine | Pittsburgh | Pennsylvania | 15282 | United States |
| Homebased Telemedicine | Austin | Texas | 78701 | United States |
| Homebased Telemedicine | Dallas | Texas | 75202 | United States |
| Homebased Telemedicine | Houston | Texas | 77002 | United States |
| Homebased Telemedicine | Richmond | Virginia | 23220 | United States |
| Homebased Telemedicine | Virginia Beach | Virginia | 23451 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALK-positive Solid Tumors | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided. | Mean | Standard Deviation | Years |
| ||||||||||
| Sex/Gender, Customized | The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided. | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response. | Posted | Number | Percentage | Approximately 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1 | BICR was not performed. | Posted | 0 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Determined by Both the Investigator and by 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. | Posted | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) 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. | Posted | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Central Nervous System (CNS) ORR 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. | Posted | Baseline up to 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | CNS DOR 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. | Posted | From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | 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. | Posted | From the first dose of study drug to death from any cause (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | Posted | Number | Percentage | Approximately 1 year |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | Posted | Number | Percentage | Approximately 1 year |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Alectinib | Plasma concentration data was not collected as the data for one participant was not sufficient. | Posted | Baseline up to 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria | 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. | Posted | Up to 5 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria | 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. | Posted | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria | 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. | Posted | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | OS in Participants With Primary CNS Tumors | 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. | Posted | From the first dose of study drug to death from any cause (up to 5 years) |
|
|
Approximately 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALK-positive Solid Tumors | 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. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | medDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia | Nervous system disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | medDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | medDRA 25.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Weight decreased | Metabolism and nutrition disorders | medDRA 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | medDRA 25.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2022 | Apr 21, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008545 | Melanoma |
| D010190 | Pancreatic Neoplasms |
| D012509 | Sarcoma |
| D010051 | Ovarian Neoplasms |
| D001932 | Brain Neoplasms |
| D013964 | Thyroid Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D018281 | Cholangiocarcinoma |
| D012468 | Salivary Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D009371 | Neoplasms by Site |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002292 | Carcinoma, Renal Cell |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013959 | Thyroid Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| D001982 | Bronchial Diseases |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582670 | alectinib |
Not provided
Not provided
Not provided
|
| Categories |
|---|
|