Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as third or fourth treatment line in subjects with progressive measurable metastatic colorectal cancer (mCRC).

Key facts

Study ID

NCT02448810

Run by

Baxalta now part of Shire

People needed

115

Starts

2015-06-15

Expected to finish

2017-02-15

Last updated by the study team

2021-05-25

Who can join

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

You may qualify if…

• Provision of a signed informed consent
• Male and female subjects 18 years of age and older at the time of screening
• Subjects who progressed after receiving at least 2, but no more than 3, prior SoC treatment lines
• Anticipated life expectancy >3 months at the time of screening
• Weight between 40 kg and 180 kg
• Histologically or cytologically confirmed diagnosis of CRC
• Metastatic CRC not amenable to surgical resection
• Known KRAS and NRAS mutation status (if unknown status for either of these genes, and no archival tissues is available, a fresh tumor biopsy will be made)
• At least 1 measurable lesion as defined by RECIST v1.1
• ECOG PS of 0-2
• Adequate hematological function, defined as:
• Platelet count ≥ 100,000/μL
• Prothrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)
• Absolute neutrophil count (ANC) ≥ 1,000/μL
• Hemoglobin ≥ 9 g/dL, without the need for transfusion in the 2 weeks prior to screening
• Adequate renal function, defined as serum creatinine ≤ 2.0 times ULN and creatinine clearance > 50 mL/min
• Adequate liver function, defined as:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
• ≤ 2.5 times ULN for subjects without liver metastases, or ≤ 5 times ULN in the presence of liver metastases
• Bilirubin ≤ 2.0 times ULN, unless subject has known Gilbert's syndrome
• Adequate venous access
• For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control measures, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90 days after the last administration of BAX69. Other acceptable contraceptive measures include birth control pills/patches or intrauterine devices
• For male subjects, the subject must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of BAX69
• Subject is willing and able to comply with the requirements of the protocol.

You may not qualify if…

• Known central nervous system metastases
• Prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of breast, in situ cervical carcinoma and superficial bladder cancer
• Prior treatment with panitumumab for subjects with KRAS and NRAS wt tumor
• Residual AE from previous treatment > Grade 1
• Prior intolerance to fluoropyrimidine for subjects with KRAS or NRAS mut tumor
• Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or long QT syndrome)
• Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg confirmed upon repeated measures
• LVEF < 40% as determined by echocardiogram performed at screening or within 90 days prior to C1D1
• QT/QTc interval > 450 msec, as determined by screening ECG performed no earlier than 1 week before C1D1
• Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to C1D1.
• Major surgery within 4 weeks prior to C1D1
• Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
• Active infection involving IV antibiotics within 2 weeks prior to C1D1
• Known history of, or active hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis
• Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease
• Subject has received a live vaccine within 4 weeks prior to C1D1
• Known hypersensitivity to any component of recombinant protein production by CHO cells
• Exposure to an investigational product or investigational device in another clinical study within 4 weeks prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
• Subject is nursing or intends to begin nursing during the course of the study
• Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
• Subject is a family member or employee of the investigator

Where it is running

• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Indiana University Health — Goshen, Indiana, United States
• Maryland Oncology Hematology, P.A. — Rockville, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• The Jones Clinic, PC — Germantown, Tennessee, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States
• CTRC at University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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