Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Patients will receive BBI608 orally continuously at 200mg BID. 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.

Patients will receive BBI608 orally continuously at 240mg BID. 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.

Patients will receive BBI608 orally continuously at 400mg BID. 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.

Patients will receive BBI608 orally continuously at 480mg BID. 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.

Patients will receive BBI608 orally continuously at 500mg BID. 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.

BBI608

Claudia Lebedinsky, MD

This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.

This is an open label, multi-center, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced solid tumors for whom weekly paclitaxel is an acceptable option.

A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

Assessment of safety of napabucasin administered in participants with advanced malignancies for whom weekly paclitaxel was an acceptable option by reporting of adverse events and serious adverse events

Determination of the Recommended Phase 2 dose (RP2D) of napabucasin when administered with paclitaxel in patients with advanced malignancies.

To determine the maximum concentration of napabucasin and the area under the plasma concentration vs. time curve of napabucasin when administered in combination with weekly paclitaxel

To assess the preliminary anti-tumor activity, specifically the objective response rate (ORR) of napabucasin administered in combination with paclitaxel. The Objective Response Rate (ORR) is the proportion of participants with a complete response or partial response who have measurable disease at baseline imaging.

Assessment of the objective response rate (ORR) of napabucasin administered in combination with paclitaxel in patients with advanced malignancies.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; The Objective Response Rate (ORR) is the proportion of participants with a complete response or partial response.

To determine the disease control rate (CDR) of napabucasin administered in combination with paclitaxel in patients with advanced malignancies.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The Disease Control Rate (DCR) is the proportion of patients whose best overall response is CR, PR or SD.

The effect of napabucasin given in combination with paclitaxel on Progression Free Survival (PFS) of patients with advanced malignancies.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

The effect of napabucasin given in combination with paclitaxel on Overall Survival (OS) of patients with advanced malignancies

To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin

Sumitomo Pharma America, Inc.

Participants received napabucasin 200mg administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin 200mg BID Plus Paclitaxel

Participants received napabucasin 240mg administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin 240mg BID Plus Paclitaxel

Participants received napabucasin 400mg administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin 400mg BID Plus Paclitaxel

Participants received napabucasin 480mg administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin 480mg BID Plus Paclitaxel

Participants received napabucasin 500mg administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin 500mg BID Plus Paclitaxel

Participants received napabucasin 200mg BID administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Participants received napabucasin 240mg BID administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Participants received napabucasin 400mg BID administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Participants received napabucasin 480mg BID administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Participants received napabucasin 500mg BID administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Total

Age, Continuous

Sex: Female, Male

Caucasian

Hispanic

Black

Asian

Other

Race/Ethnicity, Customized

Tegan Nguyen

Number of Participants With Adverse Events and Serious Adverse Events

All participants who were enrolled into the trial received napabucasin administered orally, twice daily, in combination with a fixed dose of paclitaxel administered IV weekly on day 3, 10 and 17 of each 28 day cycle.

Napabucasin (BBI608) Plus Paclitaxel

The Phase 1b portion of the study consisted of the first 24 patients enrolled in the study. These 24 patients, who received at least one dose of study drug, comprised the DLT Analysis Set.

Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)

Sponsor's decision to terminate further development of the napabucasin program. Data were not collected.

Determination of the Maximum Observed Concentration (Cmax) and Area Under the Plasma Concentration vs. Time Curve (AUClast)

Preliminary Anti-tumor Activity of BBI608 When Administered in Combination With Paclitaxel in Patients With Advanced Malignancies

Patients had a baseline scan and at least 1 disease assessment following the initiation of therapy.

The Objective Response Rate of Napabucasin Administered in Combination With Paclitaxel in Patients With Advanced Malignancies

Patients who received at least 1 cycle of study treatment and had at least 1 disease assessment following the initiation of therapy. Patients missing imaging assessment following the initiation of treatment are not included in the assessment for DCR.

Disease Control Rate

Patients had a baseline scan and at least 1 on study scan or died from any cause.

Progression Free Survival of Patients With Advanced Malignancies

Overall Survival of Patients With Advanced Malignancies

No on-treatment biopsies were performed therefore no pharmacodynamic testing on tumor tissue was conducted.

Spots Global Cancer Trial Database for A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies

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