Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or… (NCT02321501) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
United States37 participantsStarted 2016-06-22
Plain-language summary
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or stage IIIB-IV non-small cell lung cancer. Ceritinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For dose escalation cohort: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed at least one line of therapy
* For dose expansion cohort: patients with stage IIIB or IV ALK + NSCLC who have failed at least one line of therapy and are progressing on an ALK inhibitor; for dose expansion, patients who have ROS1 rearrangement testing by either next generation sequencing (NGS) or fluorescence in situ hybridization (FISH) will be eligible
* Absolute neutrophil count (ANC) \>= 1,500/microliter
* Platelets \>= 100,000/microliter
* Hemoglobin (Hgb) \>= 9 g/dL
* Creatinine =\< 1.5 x upper limit of normal (ULN)
* Prothrombin time (PT), partial thromboplastin time (PTT) =\< 1.5 x ULN
* Total bilirubin =\< 1.5 x ULN
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< 1.5 x ULN (\< 5 x ULN if patient has liver metastasis)
* Patient will have a tumor suitable for fine needle aspirates (FNA) or core biopsy for research purposes (2 or more FNAs if core is not feasible)
* Able to swallow oral medications
* Patient must have performance status =\< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
* Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, or lesions which do not fulfill RECIST criteria for metastatic disease)
* ALK-positive NSCLC patients with asymptomatic central nervous system (CNS) metastases who are neurologically stable or have not requ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose of ceritinib combined with everolimus, what does that mean for what's currently known about whether this combination is safe or effective for my specific situation?
2My tumor would need to be ALK-positive or have a ROS1 gene rearrangement to be relevant here — has my tumor been tested for these, and if not, should it be before we discuss options like this?
3The trial is active but no longer enrolling new patients, so is there any way to discuss findings from this study with you that might still inform my treatment plan, or are there follow-on trials building on this combination?
4How does combining ceritinib, which targets ALK and ROS1, with everolimus, which targets a different pathway called mTOR, compare to using ceritinib alone as a treatment approach for my stage of non-small cell lung cancer?
5If I were considering a dose-finding trial like this one, how would the uncertainty about the right dose levels affect the risks I might face compared to sticking with a standard approved treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of ceritinib and everolimus, defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity