Trial Outcomes & Findings for 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 (NCT NCT02826161)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

36 months

Results posted on

2023-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Napabucasin Plus Paclitaxel All participants were randomized to receive napabucasin (BBI-608) 240 mg administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; once weekly ( three out of every four weeks)	Paclitaxel Only All participants were randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks)
Overall Study STARTED	1	3
Overall Study Discontinued Due to Treatment Related AE	1	0
Overall Study Discontinued Due to Death	0	1
Overall Study Discontinued Due to Patient Withdrawal	0	1
Overall Study Discontinued Due to Withdrawal of ICF From Further FU	1	1
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Napabucasin Plus Paclitaxel n=1 Participants All participants randomized to receive napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; once weekly ( three out of every four weeks)	Paclitaxel Only n=3 Participants All participants randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks)	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

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 in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference

To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Progression Free Survival (PFS) of patients with previously treated advanced, non-squamous non-small cell lung cancer. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Progression Free Survival (PFS) of patients with previously treated advanced, non-squamous non-small cell lung cancer in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference

To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Disease Control Rate (DCR) of patients with previously treated advanced, non-squamous non-small cell lung cancer. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with previously treated advanced, non-squamous non-small cell lung cancer with napabucasin plus weekly paclitaxel versus weekly paclitaxel.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Disease Control Rate (DCR) of patients with previously treated advanced, non-squamous non-small cell lung cancer. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The study was terminated early by the sponsor after 4 patients were randomized (3 to the control arm and 1 to receive napabucasin). Due to the small sample size, no data summaries were performed and there is no analysis for statistical interference.

All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.

Outcome measures

Outcome data not reported

Adverse Events

Napabucasin+Paclitaxel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Paclitaxel Only

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Napabucasin+Paclitaxel n=1 participants at risk All participants part of the safety population ( those who received at least 1 dose of study drug napabucasin).	Paclitaxel Only n=2 participants at risk All participants part of the safety population ( those who received at least 1 dose of paclitaxel).
Gastrointestinal disorders Diarrhea	100.0% 1/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Gastrointestinal disorders Nausea	100.0% 1/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Gastrointestinal disorders Vomiting	100.0% 1/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	0.00% 0/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Gastrointestinal disorders Costipation	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Infections and infestations Abdominal Infection	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Nervous system disorders Dysgeusia	100.0% 1/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	0.00% 0/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	0.00% 0/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
General disorders Asthenia	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months
General disorders Edema Lower Legs	0.00% 0/1 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months	50.0% 1/2 • The safety documentation and reporting begins with completion of the informed consent and extends until 30 days following the last dose of the protocol therapy, the total period is 36 months

Additional Information

Matthew Hitron, MD

Sumitomo Dainippon Pharma Oncology

Phone: 617-674-6800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Before submission for publication or presentation, Institution and/or Investigator shall allow Sponsor not less than sixty ( 60) days to review any manuscript and not less than thirty ( 30) days to review any poster presentation, abstract or any other written or oral material which describes or discloses the study results. If Sponsor requests in writing, institution and/or Investigator shall withhold any publication or presentation for an additional sixty ( 60) days.
Publication restrictions are in place

Restriction type: OTHER