*Cliff’s Notes*: There was an exclusion in the earlier trials for prior treatment with Irinotecan, but that exclusion has been lifted from the Expanded Access program now in effect.
OK, here’s the deal about
IRINOTECAN:
In the original trials, including a Phase II efficacy trial as late as this spring (’12), patient’s prior treatment of Irinotecan, or more than one prior regimen of FolFOX, was exclusionary from the trials.
This spring trial consisted of Folfiri + Regorafenib in Arm A, and Folfiri + placebo in Arm B.
I think this is the trial that was stopped because the Regorafenib was showing such great success.
See:
http://clinicaltrials.gov/ct2/show/NCT01298570 Here are the current eligibility criteria for the present Expanded Access program:
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
• Male or female subjects 18 years of age
• Life expectancy of at least 3 months
• Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
• Subjects with metastatic colorectal cancer (Stage IV)
• Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
• ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
• Adequate bone marrow, liver and renal function
• Women of childbearing potential and men must agree to use adequate contraception
Exclusion Criteria:
• Prior treatment with regorafenib
• Congestive heart failure >/= New York Heart Association (NYHA) class 2
• Uncontrolled hypertension (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
• Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
• Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours)
• Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity </= Grade 2
Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during
See:
http://clinicaltrials.gov/ct2/show/NCT01538680 * * * *
Summary: There was an exclusion in the earlier trials for prior treatment with Irinotecan, but that exclusion has been lifted from the Expanded Access program now in effect.
HTH, Rick