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 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:
* 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…
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