BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02608229 |
Recruitment Status :
Terminated
(Adverse events)
First Posted : November 18, 2015
Results First Posted : May 1, 2020
Last Update Posted : April 21, 2021
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Sponsor:
Washington University School of Medicine
Collaborators:
BioMed Valley Discoveries, Inc
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Pancreatic Cancer Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer |
Interventions |
Drug: BVD-523 Drug: Nab-paclitaxel Drug: Gemcitabine Procedure: Tumor biopsy |
Enrollment | 18 |
Participant Flow
Recruitment Details | The study opened to participant enrollment on 06/06/2016 and closed to participant enrollment on 08/19/2019. |
Pre-assignment Details |
Arm/Group Title | Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine | Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine |
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Period Title: Overall Study | ||
Started | 10 | 8 |
600 mg BVD-523 | 10 | 2 |
450 mg BVD-523 | 0 | 6 |
Completed | 10 | 8 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dose De-escalation: BVD-523/Nab-paclitaxel/Gemcitabine | Dose Expansion: BVD-523/Nab-paclitaxel/Gemcitabine | Total | |
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Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 8 | 18 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 10 participants | 8 participants | 18 participants | |
65.5
(55 to 74)
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61.5
(37 to 78)
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63.5
(37 to 78)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 8 participants | 18 participants | |
Female |
3 30.0%
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2 25.0%
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5 27.8%
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Male |
7 70.0%
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6 75.0%
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13 72.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 8 participants | 18 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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|
Not Hispanic or Latino |
10 100.0%
|
8 100.0%
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18 100.0%
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 8 participants | 18 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
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|
Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
10 100.0%
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7 87.5%
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17 94.4%
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More than one race |
0 0.0%
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1 12.5%
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1 5.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 10 participants | 8 participants | 18 participants |
10 | 8 | 18 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Kian-Huat Lim, M.D., Ph.D. |
Organization: | Washington University School of Medicine |
Phone: | 314-362-6157 |
EMail: | kian-huat.lim@wustl.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT02608229 |
Other Study ID Numbers: |
201601098 5P50CA196510-02 ( U.S. NIH Grant/Contract ) |
First Submitted: | November 16, 2015 |
First Posted: | November 18, 2015 |
Results First Submitted: | March 27, 2020 |
Results First Posted: | May 1, 2020 |
Last Update Posted: | April 21, 2021 |