Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kina… (NCT02521051) | Clinical Trial Compass
TerminatedPhase 1/2
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
Stopped: slow accrual
United States11 participantsStarted 2015-09-28
Plain-language summary
This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed advanced, non-squamous, non-small cell lung cancer.
* Molecular confirmation of an ALK rearrangement.
* Age ≥ 18 years old.
* Life expectancy \> 12 weeks.
* Performance status 0-2.
* Adequate hematologic function:
* Adequate renal function:
* An estimated Glomerular Filtration Rate (eGFR) of at least 45 mL/min/1.73 m2
* International normalized ration (INR)≤ 1.5
* Partial thromboplastin time (PTT) ≤1.5 x upper limit of normal (ULN)
* For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment.
* Able and willing to provide written informed consent
* Phase II Only:
* Presence of at least one measurable central nervous system (CNS) target lesion (At least 5 mm in size)
* Lesions must be untreated or progressive according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after previous local therapy.
* Participants who are receiving corticosteroids must be on a stable or decreasing dose
* At least one measurable extra-CNS lesion based upon RECIST version 1.1.
Exclusion Criteria:
* Squamous cell histology or mixed, predominantly squamous adenosquamous carcinoma
* Previous history of haemoptysis
* Tumour infiltrating into large vessels or infiltrating into the proximal tracheobronchial network
* Unstable, symptomatic brain metastases.
* History of hemorrhagic CNS metastases
* History of intracranial hemorrhage (ei…
What they're measuring
1
(Phase 1) Recommended Phase II Dose of Alectinib
Timeframe: first cycle of treatment (21 days)
2
(Phase 1) Recommended Phase II Dose of Bevacizumab
Timeframe: first cycle of treatment (21 days)
3
(Phase 2) Number of Participants With Intracranial Hemorrhagic Events Who Received RP2D