Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jennerex Biotherapeutics
With
Transgene
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
Failed treatment with irinotecan
Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
Regorafenib-naïve (have not received regorafenib)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Measurable tumor (≥1 cm longest diameter)
Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)
You may not be if
Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
Significant immunodeficiency due to underlying illness and/or medication
History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms
Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
Pregnant or nursing an infant
Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
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