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About
This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.
Full description
This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.
Enrollment
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Inclusion criteria
Signed written informed consent
A histologically confirmed solid tumor of the gastrointestinal tract including
Patients may be treatment naïve, or may have received standard chemotherapy; including regimens containing a fluoropyrimidine, or oxaliplatin, or irinotecan, or regorafenib, or bevacizumab.
≥18 years of age.
Karnofsky performance status score ≥70%.
Male or female patients of child-producing potential agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose.
Females of childbearing potential have a negative serum pregnancy test.
AST level ≤2.5 x ULN and ALT ≤ 2.5 × ULN. For patients with liver metastases, AST ≤3.5 x ULN, and AST ≤3.5 x ULN may be enrolled if agreed upon by the investigator and medical monitor for the sponsor.
Hemoglobin ≥10 g/dl.
Total bilirubin level ≤1.5 × ULN.
Creatinine ≤1.5 x ULN or creatinine clearance >60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (as determined by Cockcroft-Gault equation).
Absolute neutrophil count ≥ 1.5 x 10^9/L.
Platelets ≥100 x 10^9/L.
Life expectancy estimated at ≥3 months.
Exclusion criteria
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of the first dose of BBI608.
Major surgery within 4 weeks prior to first dose.
Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
Pregnant or breastfeeding.
Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent
Unable or unwilling to swallow BBI608 capsules daily.
Prior treatment with BBI608.
Uncontrolled intercurrent illness
For patients to be treated with a regimen containing 5-fluorouracil/leucovorin:
For patients to be treated with a regimen containing capecitabine:
For patients to be treated with a regimen containing oxaliplatin:
For patients to be treated with a regimen containing irinotecan:
For patients to be treated with a regimen containing bevacizumab:
For patients to be treated with a regimen containing regorafenib:
Primary purpose
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495 participants in 7 patient groups
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Data sourced from clinicaltrials.gov
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