A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT01325441|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : July 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: BBI608 Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||565 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 1, 2021|
|Actual Study Completion Date :||June 1, 2021|
Experimental: BBI608 and Paclitaxel
Patients will receive BBI608 orally continuously at dose levels specified for their respective dose cohorts. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted.
Other Name: Abraxane
- Safety by reporting the adverse events and serious adverse events [ Time Frame: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 6 months ]Assessment of safety of napabucasin given in combination with paclitaxel in patients with advanced malignancies by reporting of adverse events and serious adverse events.
- Determination of the Recommended Phase 2 Dose by assessing dose-limiting toxicities (DLTs) [ Time Frame: 6 months ]Determination of the Recommended Phase 2 dose (RP2D) of napabucasin when administered with paclitaxel in patients with advanced malignancies.
- Preliminary anti-tumor activity of BBI608 when administered in combination with paclitaxel in patients with advanced malignancies by performing tumor assessments every 8 weeks [ Time Frame: Anti-tumor activity is assessed every 8 weeks, from the first dose of BBI608 to 30 days after the last dose of BBI608, an expected average of 6 months ]To assess the preliminary anti-tumor activity of napabucasin administered in combination with paclitaxel.
- Pharmacokinetic profile of BBI608 and paclitaxel assessed by area under the plasma concentration versus time curve [ Time Frame: On Day 3 and Day 17 of the first cycle prior to dosing and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 8.5, 9, 10, 11, 24 and 27 hours after first dose ]Blood sampling to assess the pharmacokinetic profile of BBI608 administered in combination with paclitaxel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325441
|Study Director:||Claudia Lebedinsky, MD||Sumitomo Dainippon Pharma Oncology, Inc|