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

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Brief Title

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

Official Title

Phase II Study to Evaluate the Activity of Commercially Available Molecularly Matched Targeted Therapies in Selected Tumor Types Based on Genomic Alterations

Brief Summary

      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.
    

Detailed Description

      This four-arm pilot phase II study will evaluate the preliminary antitumor activity of
      selected commercially available molecularly matched targeted therapies in patients who have
      failed first line treatment for one of the following tumor types:

        1. non-small cell lung cancer,

        2. urothelial carcinoma,

        3. non-colon gastrointestinal cancers, and

        4. upper aerodigestive tract cancers (lip, tongue, salivary glands, gum, mouth, oral
           cavity, tonsils, oropharynx, nasopharynx, nasal cavity, sinus, and larynx tumors).

      Approximately 160 patients (40 per tumour type) are planned for enrollment. Consideration for
      enrollment will be based on results from profiling with next-generation sequencing technology
      that was performed outside of the protocol. Eligible patients will receive one of the
      FDA-approved targeted agents at the recommended dose. The treating physician will decide
      which targeted agent to prescribe based on the genomic alterations per tumor type and the
      targets listed in the package insert for each agent.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR)

Secondary Outcome

 Clinical benefit rate

Condition

Non-small Cell Lung Carcinoma

Intervention

afatinib

Study Arms / Comparison Groups

 Arm 1
Description:  Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

160

Start Date

September 28, 2016

Completion Date

December 30, 2021

Primary Completion Date

December 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. 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:

               1. Non-small cell lung cancer

               2. Urothelial carcinoma

               3. Non-colon gastrointestinal cancers (including hepatobiliary, pancreatic, and
                  gastroesophageal tumors)

               4. Upper aerodigestive tract cancers (including lip, tongue, salivary gland, gum,
                  oral cavity, mouth, tonsils, oropharynx, nasopharynx, nasal cavity, sinus, and
                  larynx tumors)

          2. Patients must have a predefined genomic alteration that can be targeted with any of
             the FDA-approved targeted agents used in this study.

          3. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

          5. Age greater than or equal to 18 years.

          6. Adequate hematologic function defined as:

               -  Absolute neutrophil count (ANC) ≥1500/μL

               -  Platelets ≥75,000/μL

          7. 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)

          8. 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.

          9. 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.

         10. 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.

         11. Willingness and ability to comply with study and follow-up procedures.

         12. Ability to understand the nature of this study and give written informed consent.

        Exclusion Criteria:

          1. Two or more prior chemotherapy regimens in the metastatic setting.

          2. Most recent chemotherapy ≤ 3 weeks and > Grade 1 chemotherapy-related side effects,
             with the exception of neuropathy (> grade 2 excluded) and alopecia.

          3. 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.

          4. 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.

          5. Major surgical procedures ≤28 days of beginning study drug, or minor surgical
             procedures ≤7 days. No waiting required following port-a-cath placement.

          6. 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.

          7. Pregnant or lactating

          8. Acute or chronic liver, renal, or pancreas disease.

          9. Presence of active gastrointestinal disease or other condition that will interfere
             significantly with the absorption, distribution, metabolism, or excretion of oral
             therapy.

         10. 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

         11. Inadequately controlled hypertension.

         12. 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.

         13. 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.

         14. For patients receiving cabozantinib only: Do not administer cabozantinib to patients
             that have high risk or at high risk for severe haemorrhage. Examples include:

               1. The patient has radiographic evidence of cavitating pulmonary lesion(s).

               2. The patient has tumor invading or encasing any major blood vessels.

               3. The patient has had hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3
                  months before the first dose of study treatment.

               4. The patient has experienced clinically significant GI bleeding within 6 months of
                  the first dose of study treatment.

               5. The patient has experienced any other signs indicative of pulmonary hemorrhage
                  within 3 months of the first dose of study treatment.

         15. For patients receiving cabozantinib only: Do not administer cabozantinib to patients
             that have high risk or at high risk of perforation or fistula:

               1. The patient has evidence of tumor invading the GI tract, active peptic ulcer
                  disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis,
                  cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute
                  obstruction of the pancreatic duct or common bile duct, or gastric outlet
                  obstruction.

               2. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess
                  within 6 months before first dose. Note: Complete healing of an intra-abdominal
                  abscess must be confirmed before first dose.

               3. The patient has pre-existing fistula of head and neck area. Note: Treatment areas
                  should be healed with no sequelae from prior radiation therapy that would
                  predispose to fistula formation.

               4. The patient has pre-existing osteonecrosis of the jaw.

         16. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet
             inhibitors. [Patients receiving cabozantinib only]

         17. Note: Low-dose aspirin for cardioprotection (per local applicable guidelines),
             low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are
             permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects
             without radiographic evidence of brain metastasis, who are on a stable dose of LMWH
             for at least 12 weeks before randomization, and who have had no complications from a
             thromboembolic event or the anticoagulation regimen.Presence of a non-healing wound,
             non-healing ulcer, or bone fracture.

         18. Patients with phaeochromocytoma.

         19. Serious active infection at the time of treatment, or another serious underlying
             medical condition that would impair the ability of the patient to receive protocol
             treatment.

         20. Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C.

         21. Presence of other active cancers unless indolent and not requiring therapy. Patients
             with Stage I cancer who have received definitive local treatment and are considered
             unlikely to recur are eligible. All patients with previously treated in situ carcinoma
             are eligible, as are patients with history of non-melanoma skin cancer.

         22. Psychological, familial, sociological, or geographical conditions that do not permit
             compliance with the protocol.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Howard A. Burris, III, MD, 844-710-6157, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02795156

Organization ID

SCRI PRO 10


Responsible Party

Sponsor

Study Sponsor

SCRI Development Innovations, LLC

Collaborators

 Foundation Medicine

Study Sponsor

Howard A. Burris, III, MD, Study Chair, SCRI Development Innovations, LLC


Verification Date

January 2021