Clinical Trials /

TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

NCT03686488

Description:

The purpose of this study is to find out if the combination of TAS 102 and Ramucirumab is safe and effective in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Official Title: A Phase II Study of TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: MCC-19477
  • NCT ID: NCT03686488

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer

Interventions

DrugSynonymsArms
TAS 102LonsurfTAS 102 and Ramucirumab
Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]TAS 102 and Ramucirumab

Purpose

The purpose of this study is to find out if the combination of TAS 102 and Ramucirumab is safe and effective in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Trial Arms

NameTypeDescriptionInterventions
TAS 102 and RamucirumabExperimentalTAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
  • TAS 102
  • Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of gastric and GEJ adenocarcinoma.

          -  Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumors
             (RECIST) 1.1. Stage IV or recurrent disease is required. An irradiated lesion is
             considered evaluable only if it has shown enlargement since the completion of last
             radiation.

          -  Participants must have received and progressed with prior therapy. Prior therapy with
             ramucirumab is not allowed. Participants must have recovered from the toxic effects of
             the previous anti-cancer chemotherapy (with the exception of alopecia).

          -  Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1

          -  Estimated life expectancy > 3 months

          -  Adequate bone marrow, liver and renal function as assessed by the following:
             Hemoglobin > 8.0 g/dl, Absolute neutrophil count (ANC) > 1,000/mm3 independent of
             growth factor support, Platelet count > 100,000/mm3, Total bilirubin < 1.5 times upper
             limits of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of
             non-hepatic origin, aspartate transaminase (AST), alanine transaminase (ALT) and
             Alkaline Phosphatase ≤2.5 times the ULN ( ≤5 x ULN for patients with liver
             involvement), Creatinine clearance ≥ 30 ml/min.

          -  Participants must not have had chemotherapy,major surgery, monoclonal antibody therapy
             or experimental therapy within the 28 days prior to the start of TAS 102
             administration.

          -  Women of childbearing potential must have a negative serum pregnancy test performed
             within 7 days prior to the start of study drug. Post-menopausal women (defined as no
             menses for at least 1 year) and surgically sterilized women are not required to
             undergo a pregnancy test.

          -  Participants (men and women) of childbearing potential must agree to use adequate
             contraception beginning at the signing of the informed consent form until at least 4
             months for both females and males after the last dose of study drug. The definition of
             adequate contraception will be based on the judgment of the principal investigator or
             a designated associate.

          -  Participants must be able to understand and be willing to sign the written informed
             consent form. A signed informed consent form must be appropriately obtained prior to
             the conduct of any trial-specific procedure. Subjects must be willing and able to
             comply with scheduled visits, treatment schedule, laboratory testing, and other study
             requirements.

        Exclusion Criteria:

          -  Participants with active Central Nervous System (CNS) metastases are excluded. If CNS
             metastases are treated and participants are at neurologic baseline for at least 2
             weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to
             enrollment.

          -  Women who are pregnant or breast-feeding.

          -  Prior therapy with ramucirumab, bevacizumab, regorafenib or TAS 102.

          -  Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for
             curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial
             bladder 15 tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor
             invades lamina propria)].

          -  Uncontrolled hypertension (systolic BP >140 mm Hg or diastolic BP >90 mm Hg on
             repeated measurement despite optimal medical management)

          -  Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of
             study medication.

          -  Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of
             study medication.

          -  Persistent proteinuria ≥ Grade 3 on repeated measurement.

          -  Substance abuse, medical, psychological or social conditions that may interfere with
             the patient's participation in the study or evaluation of the study results.

          -  Participants with an arterial thrombotic or thromboembolic event within 12 months of
             informed consent.

          -  Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks

          -  Known history of human immunodeficiency virus (HIV) infection or current chronic or
             active hepatitis B or C infection requiring treatment with antiviral therapy.

          -  Clinically significant cardiovascular disease such as unstable angina, uncontrolled or
             symptomatic arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as
             defined by the New York Heart Association Functional Classification, or history of
             myocardial infarction within 6 months prior to first dose with study drug.

          -  Unable to swallow capsules or disease significantly affecting gastrointestinal
             function and/or inhibiting small intestine absorption such as; malabsorption syndrome,
             resection of the small bowel, or poorly controlled inflammatory bowel disease
             affecting the small intestine.

          -  Child-Pugh B cirrhosis (or worse) or a history of hepatic encephalopathy

          -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

          -  Any illness or medical conditions that are unstable or could jeopardize the safety of
             the patient and his/her compliance in the study.

          -  Major surgery or a wound that has not fully healed within 4 weeks of enrollment.

          -  Patients who need anticancer chemotherapy other than the study drugs during the study
             or within 4 weeks of study enrollment. Anti-cancer therapy is defined as any agent or
             combination of agents with clinically proven anti-tumor activity administered by any
             route with the purpose of affecting the malignancy, either directly or indirectly,
             including palliative and therapeutic endpoints.

          -  Patients who need hormonal therapy during the study or within 2 weeks of first study
             enrollment.

          -  Patients who need radiotherapy to target lesions during study or within 2 weeks of
             enrollment.

          -  Patients who had bone marrow transplant or stem cell rescue.

          -  Patients who need investigational drug therapy outside of this trial during or within
             4 weeks of first study treatment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival
Time Frame:6 months
Safety Issue:
Description:Overall survival defined as the time from starting on trial to date of death from any cause.

Secondary Outcome Measures

Measure:Number of participants with at least one adverse event
Time Frame:4 weeks after end of study participation
Safety Issue:
Description:Frequency and severity of adverse events
Measure:Objective Response Rate (ORR)
Time Frame:6 months
Safety Issue:
Description:Response Evaluation Criteria in Solid Tumors (RECIST) based response rate
Measure:Progression Free Survival (PFS)
Time Frame:6 months
Safety Issue:
Description:PFS, defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

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