Metastatic Pancreatic Adenocarcinoma and Metastatic Colorectal Cancer.
Conditions
Interventions
Product Name: Napabucasin
Product Code: BBI-608
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Napabucasin
CAS Number: 83280-65-3
Other descriptive name: NAPABUCASIN, BBI-608, BBI608, BB608
C
Sponsors
Boston Biomedical, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is currently participating in a BBI-sponsored parent study of napabucasin and must be receiving napabucasin as monotherapy or a part of a combination treatment. 2. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonisation (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure. 3. Must be =18 years of age. 4. Currently has no evidence of progressive disease, as determined by the investigator, during treatment with napabucasin (either as monotherapy or as part of a combination treatment regimen) or are deriving clinical benefit despite disease progression according to Investigator's clinical judgement. 5. Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome. 6. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening. 7. Non-fertile or agree to use an adequate method of contraception while on study and for 6 months following the last dose and not currently nursing; males agree to use an adequate method of contraception while on study and for 3 months following the last dose. 8. Patients must be accessible for treatment and follow-up. Patients registered on this trial must receive protocol treatment and be followed at their current (parent study) participating center. 9. Patient agrees not to participate in other interventional clinical studies during their participation in this trial. Patients participating in surveys or observational studies are eligible to participate in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Permanent discontinuation of napabucasin in the parent study. 2. Napabucasin dose interruption for >4 weeks between the last dose on the parent study and first dose on the rollover study. 3. Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin. Women undergoing combination backbone therapy should not breast feed while on combination backbone therapy and for the period of time following discontinuation of combination backbone therapy as specified in the parent protocol. 4. Hypersensitivity to napabucasin or one of the excipients. 5. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy. 6. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of napabucasin through the evaluation of AEs, clinically significant physical examination findings, and clinically relevant laboratory results.;Secondary Objective: Not applicable;Primary end point(s): 1. Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE versión 4.0), seriousness, and relationship to study therapy. 2. Laboratory abnormalities as characterized by type, frequency, and severity (as graded by NCIC version 4.0). 3. Vital signs. 4. Physical examination. 5. ECG.;Timepoint(s) of evaluation of this end point: 1. At screening, at cycle 1, at additional cycles and at the safety follow-up visit. 2. At screening, at cycle 1, at additional cycles and at the safety follow-up visit. 3. At screening, at cycle 1, at additional cycles and at the safety follow-up visit. 4. At screening, at cycle 1, at additional cycles and at the safety follow-up visit. 5. At screening. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
France, Taiwan, United States
Contacts
Public ContactClinical Trial Office
Boston Biomedical, Inc.
Outcome results
None listed