A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

NCT02826161 | Terminated Phase 3 Results DMC

• 1 other identifier: CanStem43L
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

Brief Summary

This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Neoplasms; Neoplasms by Site; Lung Neoplasms; Thoracic Neoplasms; Respiratory Tract Neoplasms; Bronchial Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Overall Survival of patients with previously treated advanced, non-squamous non-small cell lung cancer.

  36 months

Secondary Outcomes (7)

• Overall Survival in Biomarker Positive Patients

  36 months

• Progression Free Survival

  36 months

• Progression Free Survival in Biomarker Positive Patients

  36 months

• Disease Control Rate in Biomarker Positive Patients

  36 months

• Quality of Life (QoL)

  36 months

Study Arms (2)

Napabucasin plus Weekly Paclitaxel

EXPERIMENTAL

Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with paclitaxel administered intravenously, once weekly, on 3 of every 4 weeks.

Drug: Napabucasin; Drug: Paclitaxel

Weekly Paclitaxel

ACTIVE COMPARATOR

Patients randomized to this arm will receive weekly paclitaxel alone administered intravenously, once weekly, on 3 of every 4 weeks.

Drug: Paclitaxel

Interventions

Napabucasin DRUG

Napabucasin will be administered in continuous 28-day cycles. The starting dose of napabucasin is 240 mg twice daily (480 mg total daily dose) with approximately 12 hours between each dose. Napabucasin should be taken with fluids either 1 hour prior to a meal or 2 hours after a meal.

Also known as: BBI-608, BBI608, BB608

Napabucasin plus Weekly Paclitaxel

Paclitaxel DRUG

Paclitaxel will be administered intravenously, once weekly, via one-hour infusion at a starting dose-level of 80 mg/m\^2 body surface area. The weekly paclitaxel infusion will be given during 3 out of every 4 weeks, on days 1, 8, and 15 of each 28-day study cycle.

Napabucasin plus Weekly Paclitaxel; Weekly Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have histologically or cytologically confirmed non-squamous NSCLC.
• Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
• Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
• Weekly paclitaxel must be an acceptable treatment option
• Must submit tumor tissue for correlative analyses
• Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months

You may not qualify if:

• Has squamous NSCLC
• Has received prior systemic treatment with a taxane for advanced/metastatic disease
• Has received systemic anti-cancer therapy within the 14 days prior to randomization
• Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
• Has brain metastases with evolving neurologic symptoms or a steroid requirement.
• Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
• Has a corrected QT interval (QTc) \> 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
• Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
• Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
• Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (5)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Santa Rosa, California, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Gettysburg, Pennsylvania, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Neoplasms by Site; Lung Neoplasms; Thoracic Neoplasms; Respiratory Tract Neoplasms; Bronchial Neoplasms

Interventions

napabucasin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

On 12 June 2017 the sponsor notified study investigator that the study was terminated because of the rapidly evolving standard of care for patients with NSCLC. At the time of the termination, there were only 4 patients randomized (3 to the control arm and 1 to the napabucasin arm). Due to the small sample size, neither safety or efficacy data were analyzed or summarized for this study.

Results Point of Contact

• Title: Matthew Hitron, MD
• Organization: Sumitomo Dainippon Pharma Oncology

mhitron@bostonbiomedical.com

617-674-6800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 7, 2016
• Study Start: November 1, 2016
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: November 15, 2023
• Results First Posted: June 15, 2021

Record last verified: 2023-11

Locations

US (5)