Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02521051|
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Alectinib Drug: Bevacizumab||Phase 1 Phase 2|
This is a Phase I/II clinical trial.
- A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose(s) of the investigational intervention to use for further studies.
- Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease.
"Investigational" means that the intervention is being studied.
- In this research study, the investigators are investigating the combination of two study drugs: alectinib and bevacizumab. The FDA (the U.S. Food and Drug Administration) has not approved alectinib as a treatment for any disease.
It has been found that some people with NSCLC have a change (mutation) in a certain gene called the anaplastic lymphoma receptor tyrosine kinase (ALK) gene. This mutated gene helps cancer cells grow.
-- Alectinib belongs to a class of drugs designed to inhibit ALK. This drug has been used in other research studies. Information from those other research studies suggests that alectinib may be effective in killing cancer cells that have changes in ALK. Only participants with changes in the ALK gene will be allowed to participate in this study.
In this research study, Alectinib will be combined with Bevacizumab.
-- Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and nutrients that are needed for tumor growth are decreased. The FDA has approved Bevacizumab as a treatment option for your disease
The purpose of this study is to test the safety of Alectinib and Bevacizumab. The investigators will also determine how effective this combination is in participants with advanced, ALK-positive NSCLC with a focus on participants with brain metastases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial to Evaluate the Safety and Tolerability of Alectinib and Bevacizumab in Patients With Advanced, ALK-Positive, Non-Small Cell Lung Cancer|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||June 2022|
Experimental: Alectinib and Bevacizumab.
Phase II In the phase II portion of this study, the investigators will evaluate the combination of alectinib plus bevacizumab in ALK-positive patients with untreated or progressive, asymptomatic brain metastases. Eligible participants will receive alectinib plus bevacizumab at the recommended phase II doses determined in the phase I portion of the study.
Other Name: Alecensa
Other Name: Avastin
- Recommended phase II dose of the combination of Alectinib and Bevacizumab [ Time Frame: 21 Days ]Phase I Primary Endpoint: To determine the recommended phase II dose of the combination of alectinib and bevacizumab.
- Number of participants treated with the combination of alectinib and bevacizumab with adverse events [ Time Frame: 2 years ]Phase II Primary Endpoint: Safety and tolerability of alectinib and bevacizumab as assessed by Common Terminology Criteria for Adverse Events version 4.0
- Central nervous system objective response rate [ Time Frame: 2 years ]Number of subjects with intracranial complete or partial responses
- Central nervous system disease control rate [ Time Frame: 2 years ]Number of subjects with intracranial complete responses, partial responses, or stable disease
- Central nervous system progression-free survival [ Time Frame: 2 years ]Time from initiation of alectinib/bevacizumab to central nervous system progression or death.
- Overall objective response rate [ Time Frame: 2 years ]Number of subjects with partial or complete responses
- Overall disease control rate [ Time Frame: 2 years ]Number of subjects with partial/complete responses or stable disease
- Progression-free survival [ Time Frame: 2 years ]Time from initiation of alectinib/bevacizumab to progression or death.
- Quality of life: change from baseline to on-treatment, measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 [ Time Frame: 2 years ]Questionnaire
- Quality of life: change from baseline and on-treatment, measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-BN20 [ Time Frame: 2 years ]Questionnaire
- Number of patients with an ALK resistance mutation [ Time Frame: 2 years ]Determination of the number of patients who develop an ALK resistance mutation as a mechanism of resistance to alectinib and bevacizumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521051
|Contact: Justin Gainor, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Justin L. Gainor, MD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Justin Gainor, MD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02155|
|Contact: Daniel Costa, MD, PhD, MMSc 617-667-9236 email@example.com|
|Principal Investigator: Daniel Costa, MD, PhD, MMSc|
|Principal Investigator:||Justin Gainor, MD||Massachusetts General Hospital|