A Pilot Study of BXCL701 in Patients With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04123574|
Recruitment Status : Withdrawn (No longer relevant to field)
First Posted : October 11, 2019
Last Update Posted : February 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Pancreas Cancer of the Pancreas Neoplasms, Pancreatic Pancreas Cancer Pancreatic Cancer||Drug: Talabostat Mesylate||Early Phase 1|
This is a Phase 0 or "window of opportunity" study where paired specimen analysis, taken before and after drug exposure, will permit the evaluation of target modulation and assessment of immune effector cell infiltration into the tumor and the generation of relevant immune cytokines.
In this study, BXCL701 will be administered at a dose of 0.3 mg, twice daily for a total daily dose of 0.6mg (the previously defined maximum tolerated dose [MTD] of the drug), to all patients for a short period of 14 days. This study is designed to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Proof of Mechanism Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs), in Patients With Pancreatic Cancer|
|Estimated Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||December 6, 2021|
|Estimated Study Completion Date :||December 6, 2021|
Experimental: Single Arm
BXCL701 will be administered for one week at a dose of 0.2 mg, twice daily (BID). If BXCL701 is well-tolerated after the first week of treatment, the dose will be increased to 0.3mg BID for a total daily dose of 0.6mg to all patients for the second week of treatment.
Drug: Talabostat Mesylate
BXCL701 tablets dosage strengths include 0.2mg and 0.05mg tablets for oral administration.
Patients are to self-administer the prescribed number of BXCL701 tablets for a total daily dose of 0.6 mg. BXCL701 should not be taken on an empty stomach.
Daily blood pressure monitoring will be performed during the dosing period. Administration of at least 1L of intravenous (IV) fluids is required on Day 1.
On days when pharmacokinetic (PK) assessments are being performed, BXCL701 should be administered at the study center and should be administered at (approximately) the same time of day on each treatment day.
Other Name: BXCL701
- To characterize the quantitative and qualitative effects of BXCL701 on relevant immune effector cytokines and various immunological effector cells that are consistent with its known mechanism of action. [ Time Frame: Up to 37 days post treatment ]To measure how BXCL701 effects the tumor by measuring the rate of tumor cell death or the reduction of tumor cell growth. This will be measured by scans and blood work.
- Evaluate the tolerability of exposure to BXCL701: National Cancer Institute Common Terminology Criteria [ Time Frame: Up to 37 days post treatment ]assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events
- Evaluate the effect of exposure to BCXL701 on cancer cell death [ Time Frame: Up to 37days post treatment ]Measure the rate of cancer cell death measured by histological staining methods of post-treatment biopsied tissue.
- Genomic analysis before and after treatment. [ Time Frame: Up to 37 days post treatment ]Genomic analysis is the identification, measurement or comparison of genomic features such as DNA sequence, structural variation, gene expression, or regulatory and functional element annotation at a genomic scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123574
|United States, Massachusetts|
|BioXcel Clinical Research Site|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|BioXcel Clinical Research Site|
|New York, New York, United States, 10021|