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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country23 target enrollmentDecember 20, 2018

ConditionsGastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Gastric Cancer

InterventionsTAS 102 Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]

DrugsTAS 102 Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]

Overview

Phase: Phase 2
Intervention: TAS 102
Conditions: Gastric Adenocarcinoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 23
Locations: 1
Primary Endpoint: Overall Survival
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2018

End Date

May 31, 2024

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

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.
•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.

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
•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.

Arms & Interventions

TAS 102 and Ramucirumab

TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.

Intervention: TAS 102

TAS 102 and Ramucirumab

TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.

Intervention: Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 6 months

Overall survival defined as the time from starting on trial to date of death from any cause.

Secondary Outcomes

Number of Participants With at Least One Adverse Event(4 weeks after end of study participation, an average of 6.5 months)
Progression Free Survival (PFS)(6 months)
Objective Response Rate(up to 12 months)