Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations

Completed · Phase 2

Conditions studied: Non-small Cell Lung Carcinoma, Urothelial Carcinoma, Gastrointestinal Carcinoma, Non-colon, Upper Aerodigestive Tract Carcinoma

In brief

With the increased availability of next-generation sequencing, oncologists are starting to incorporate genomic profiling into routine care of cancer patients. If a genomic alteration is identified during profiling, it could help guide the choice of therapy and improve treatment outcomes. This study will examine the anti-tumor activity of selected commercially available molecularly matched targeted therapies in patients who have failed first-line treatment for one of the following tumor types: non-small cell lung cancers; urothelial cancer; non-colon gastrointestinal cancers, and upper aerodigestive tract cancer.

Key facts

Study ID

NCT02795156

Run by

SCRI Development Innovations, LLC

People needed

100

Starts

2016-09-28

Expected to finish

2022-08-17

Last updated by the study team

2023-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a histologically or cytologically confirmed diagnosis of one of the following tumor types whose disease has progressed following one line of standard therapy and/or for which no standard treatment is available that has been shown to prolong survival:
• Non-small cell lung cancer
• Urothelial carcinoma
• Non-colon gastrointestinal cancers (including hepatobiliary, pancreatic, and gastroesophageal tumors)
• Upper aerodigestive tract cancers (including lip, tongue, salivary gland, gum, oral cavity, mouth, tonsils, oropharynx, nasopharynx, nasal cavity, sinus, and larynx tumors)
• Patients must have a predefined genomic alteration that can be targeted with any of the FDA-approved targeted agents used in this study.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Age greater than or equal to 18 years.
• Adequate hematologic function defined as:
• Absolute neutrophil count (ANC) ≥1500/μL
• Platelets ≥75,000/μL
• Adequate liver function defined as:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x the upper limit of normal (ULN) or ≤ 5.0 X ULN if liver metastases present
• Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
• Adequate renal function defined as serum creatinine ≤1.5 x the upper limit of normal OR measured or calculated creatinine clearance ≥50 mL/min for patients with creatinine levels greater than or equal to 1.5 x the upper limit of normal.
• Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to receive either regorafenib or afatinib provided that their medication dose and INR/PTT are stable. Close monitoring is mandatory if the patient is receiving anticoagulants. If values are above the therapeutic range the anticoagulant doses should be modified and assessments should be repeated until stable.
• Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 90 days following last dose of study drug(s). Male patients must also refrain from donating sperm during their participation in the study and for 90 days after the last dose of study drug.
• Willingness and ability to comply with study and follow-up procedures.
• Ability to understand the nature of this study and give written informed consent.

You may not qualify if…

• Two or more prior chemotherapy regimens in the metastatic setting.
• Most recent chemotherapy ≤ 3 weeks and > Grade 1 chemotherapy-related side effects, with the exception of neuropathy (> grade 2 excluded) and alopecia.
• Use of a study drug or targeted therapy ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of study treatment is required.
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy. Enzyme-inducing anticonvulsants are contraindicated.
• Pregnant or lactating
• Acute or chronic liver, renal, or pancreas disease.
• Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
• Any of the following cardiac diseases currently or within the last 6 months:
• Unstable angina pectoris
• Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2
• Acute myocardial infarction
• Conduction abnormality not controlled with pacemaker or medication
• Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
• Valvular disease with significant compromise in cardiac function
• Inadequately controlled hypertension.
• Thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of treatment.
• Evidence or history of bleeding diathesis or coagulopathy; any haemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of treatment.
• For patients receiving cabozantinib only: Do not administer cabozantinib to patients that have high risk or at high risk for severe haemorrhage. Examples include:
• The patient has radiographic evidence of cavitating pulmonary lesion(s).
• The patient has tumor invading or encasing any major blood vessels.
• The patient has had hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment.
• The patient has experienced clinically significant GI bleeding within 6 months of the first dose of study treatment.
• The patient has experienced any other signs indicative of pulmonary hemorrhage within 3 months of the first dose of study treatment.

Where it is running

• Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States
• Florida Cancer Specialists - South — Fort Myers, Florida, United States
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States
• Florida Cancer Specialists - East — West Palm Beach, Florida, United States
• Research Medical Center - HCA Midwest — Kansas City, Missouri, United States
• Tennesse Oncology — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.