The aim of this study is to see how well an investigational drug (called BBI-608) works when it is given in combination with a standard anticancer treatment for people with advanced colon or rectal cancer.
- Conditions
- Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV).Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864
- Registration Number
- EUCTR2016-001627-31-ES
- Lead Sponsor
- Boston Biomedical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1253
1.1 Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
1.2 Must have histologically confirmed advanced CRC that is metastatic.
1.3 Must have failed treatment with one regimen containing a fluoropyrimidine, oxaliplatin and bevacizumab for metastatic disease. All patients must have received a minimum of 6 weeks of the first-line regimen that included bevacizumab, oxaliplatin and a fluoropyrimidine in the same cycle. Treatment failure is defined as radiologic progression during or < 6 months after the last dose of first-line therapy.
1.4 FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.
1.5 Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 21 days prior to randomization. Patients with either measurable disease or non-measurable evaluable disease are eligible.
1.6 Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
1.7 Must be >/= 18 years of age.
1.8 For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days for female and for male patients, of the final FOLFIRI dose. Patients who receive single agent BBI-608 without FOLFIRI must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days for female patients and 90 days for male patients, of the final BBI-608 dose.
1.9 Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG.
1.10 Must have alanine transaminase (ALT) 1.11 Must have hemoglobin (Hgb) >/= 9.0 g/dL within 14 days prior to randomization. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment.
1.12 Must have total bilirubin 1.13 Must have creatinine 50 ml/min (as calculated by the Cockcroft-Gault equation) within 14 days prior to randomization.
1.14 Must have absolute neutrophil count >/= 1.5 x 10 to the 9th power/L within 14 days prior to randomization.
1.15 Must have platelet count >/= 100 x 10 to the 9th power /L within 14 days prior to randomization. Must not have required transfusion of platelets within 1 week of baseline platelet assessment.
1.16 Other baseline laboratory evaluations must be done within 14 days prior to randomization.
1.17 Patient must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays proscribed in Section 14.6 (Correlative Studies) of this protocol may be conducted.
1.18 Patient must consent to provision of a sample of blood in order that the specific correlative marker assays proscribed in Section 14.6 (Correlative Studies) may be conducted.
1.19 Patients must be accessible for tre
2.1 Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of study medication (BBI-608 or FOLFIRI) within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of study medication.
2.2 More than one prior chemotherapy regimen administered in the metastatic setting.
2.3 Major surgery within 4 weeks prior to randomization.
2.4 Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
2.5 Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of BBI-608 or while undergoing treatment with FOLFIRI and for 180 days after the last dose of FOLFIRI.
2.6 Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal Investigator, would significantly impede the absorption of an oral agent (e.g. active Crohn’s disease, ulcerative colitis, extensive gastric and small intestine resection).
2.7 Unable or unwilling to swallow BBI-608 capsules daily.
2.8 Prior treatment with BBI-608.
2.9 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
2.10 Known hypersensitivity to 5-fluorouracil/leucovorin
2.11 Known dihydropyrimidine dehydrogenase (DPD) deficiency
2.12 Known hypersensitivity to irinotecan
2.13 Abnormal glucuronidation of bilirubin, known Gilbert’s syndrome
2.14 Patients with QTc interval > 470 milliseconds
2.15 For patients to be treated with a regimen containing bevacizumab: please refer to protocol
2.16 Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >/= 3 years.
2.17 Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
2.18 Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Please refer to protocol for further information.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method