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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 (CanStem43L)

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ClinicalTrials.gov Identifier: NCT02826161
Recruitment Status : Terminated (Change of treatment landscape and evolving standard of care)
First Posted : July 7, 2016
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Oncology, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Napabucasin
Drug: Paclitaxel
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Napabucasin Plus Paclitaxel Paclitaxel Only
Hide Arm/Group Description 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) All participants were randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks)
Period Title: Overall Study
Started 1 3
Discontinued Due to Treatment Related AE 1 0
Discontinued Due to Death 0 1
Discontinued Due to Patient Withdrawal 0 1
Discontinued Due to Withdrawal of ICF From Further FU 1 1
Completed 1 3
Not Completed 0 0
Arm/Group Title Napabucasin Plus Paclitaxel Paclitaxel Only Total
Hide Arm/Group Description 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) All participants randomized to receive Paclitaxel 80 mg/m2 IV, once weekly ( three out of every four weeks) Total of all reporting groups
Overall Number of Baseline Participants 1 3 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
  33.3%
2
  50.0%
>=65 years
0
   0.0%
2
  66.7%
2
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 4 participants
Female
1
 100.0%
3
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
3
 100.0%
4
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Survival
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival in Biomarker Positive Patients
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression Free Survival
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression Free Survival in Biomarker Positive Patients
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Disease Control Rate in Biomarker Positive Patients
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Quality of Life (QoL)
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Disease Control Rate
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants were randomized to receive either napabucasin (BBI-608) 240 mg twice daily administered orally, twice daily (480 mg total in a day) plus Paclitaxel 80 mg/m2 IV; weekly ( three out of every four weeks) or, Paclitaxel 80 mg/m2 IV, weekly ( three out of every four weeks)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Napabucasin+Paclitaxel Paclitaxel Only
Hide Arm/Group Description All participants part of the safety population ( those who received at least 1 dose of study drug napabucasin). All participants part of the safety population ( those who received at least 1 dose of paclitaxel).
All-Cause Mortality
Napabucasin+Paclitaxel Paclitaxel Only
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/2 (50.00%) 
Hide Serious Adverse Events
Napabucasin+Paclitaxel Paclitaxel Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Napabucasin+Paclitaxel Paclitaxel Only
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%) 
Gastrointestinal disorders     
Diarrhea   1/1 (100.00%)  1/2 (50.00%) 
Nausea   1/1 (100.00%)  1/2 (50.00%) 
Vomiting   1/1 (100.00%)  0/2 (0.00%) 
Costipation   0/1 (0.00%)  1/2 (50.00%) 
General disorders     
Asthenia   0/1 (0.00%)  1/2 (50.00%) 
Edema Lower Legs   0/1 (0.00%)  1/2 (50.00%) 
Infections and infestations     
Abdominal Infection   0/1 (0.00%)  1/2 (50.00%) 
Metabolism and nutrition disorders     
Dehydration   1/1 (100.00%)  0/2 (0.00%) 
Nervous system disorders     
Dysgeusia   1/1 (100.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis   0/1 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders     
Alopecia   0/1 (0.00%)  1/2 (50.00%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew Hitron, MD
Organization: Sumitomo Dainippon Pharma Oncology
Phone: 617-674-6800
EMail: mhitron@bostonbiomedical.com
Layout table for additonal information
Responsible Party: Sumitomo Dainippon Pharma Oncology, Inc
ClinicalTrials.gov Identifier: NCT02826161    
Other Study ID Numbers: CanStem43L
First Submitted: July 5, 2016
First Posted: July 7, 2016
Results First Submitted: March 22, 2021
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021