KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: Esophageal Cancer, Stomach Cancer

In brief

This dose-escalation study is to determine the safety, maximum tolerated dose (MTD) and efficacy of KD019 in combination with trastuzumab and mFOLFOX-6.

Key facts

Study ID

NCT02205463

Run by

NYU Langone Health

People needed

0

Starts

2014-12-01

Expected to finish

2017-07-01

Last updated by the study team

2014-08-01

Who can join

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

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• Pathologically confirmed diagnosis of adenocarcinoma of stomach, GEJ or esophagus (central confirmation is not required). Primary tumor or metastatic lesion must be HER2+ documented as HER2 gene amplification by FISH as positive (HER2:CEP17 ratio of ≥2.0) or IHC 3+.
• Metastatic or unresectable adenocarcinoma of stomach, GEJ, or esophagus that is evaluable or that is measurable for response as per RECIST 1.1 criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral computed tomography (CT) scan.
• Adult subjects greater than 18 years of age
• Patients who received postoperative adjuvant therapy with a single-agent fluoropyrimidine and radiation are eligible.
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
• Adequate organ and bone marrow functions defined as follows:
• oAbsolute neutrophil count >1,500 cells/ul
• Platelets >100,000/ul
• Hemoglobin >9.0g/dl
• INR < or equal to 1.5 or INR < or equal to 3 if patient is on warfarin
• Serum creatinine < or equal to 1.5 times upper limit of normal (ULN) or calculated creatinine clearance (CRCL) > or equal to 60ml/min
• Serum electrolytes within the normal range (per institution standard) during screening.
• Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or equal to 3 times ULN
• Albumin > or equal to 3g/dL
• No history of another malignancy in the past 5 years, except treated non-melanoma skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
• No coexisting medical problems of sufficient severity to limit compliance with the study
• Ability to understand and sign a written informed consent document. Patient must have willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• Female subjects of childbearing potential must have a negative serum pregnancy test prior to study entry (positive urine tests are to be confirmed by serum test).
• Female subjects of childbearing potential and males must agree to use a highly effective method of contraception (<1% per year failure rate) for the duration of study treatment and for six months after discontinuation of the study drug. Highly effective birth control methods include implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomy for males.

You may not qualify if…

• Prior treatment chemotherapy or HER2-directed therapy for metastatic gastric, GEJ or esophageal adenocarcinoma chemotherapy.
• Prior peri-operative therapy with a platinum-containing regimen.
• Angina secondary to fluoropyrimidine therapy in the adjuvant setting
• Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease.
• Major surgery within 4 weeks prior to the first dose of KD019
• Left ventricular ejection fraction (EF) <50% at baseline as measured by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO).
• Treatment with chronic immunosuppressants (e.g. cyclosporine following transplantation)
• Current known active infection with HIV, hepatitis B or C viruses
• Uncontrolled systemic disease
• Brain metastases that are:
• Untreated or
• Progressive or
• Have required any type of therapy (including radiation, surgery, steroids or anticonvulsant therapy) to control symptoms from brain metastases within 60 days prior to the first study treatment
• Leptomeningeal
• Hemorrhagic
• Subject has evidence of pre-existing idiopathic pulmonary fibrosis on CT scan at baseline
• History of an invasive secondary primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma, prostate carcinoma treated surgically or non-melanoma skin cancer.
• No other non-protocol antineoplastic agents will be permitted during this study
• Patients may not be receiving any other investigational agents.
• Women who are pregnant or lactating.
• Subject has any of the following EKG criteria:
• Corrected QT interval (QTc) of >0.47 seconds
• Finding of a left bundle branch block or right bundle bunch block
• Bradycardia defined as a heart rate of <50 beats per minute (bpm)
• Presence of a pacemaker or implantable cardioverter defibrillator (ICD)

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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