Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059
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ClinicalTrials.gov Identifier: NCT03459469 |
Recruitment Status
:
Not yet recruiting
First Posted
: March 9, 2018
Last Update Posted
: March 12, 2018
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Sponsor:
Beta Cat Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Beta Cat Pharmaceuticals, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | March 1, 2018 | ||||
First Posted Date ICMJE | March 9, 2018 | ||||
Last Update Posted Date | March 12, 2018 | ||||
Estimated Study Start Date ICMJE | March 15, 2018 | ||||
Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To evaluate the safety and tolerability [ Time Frame: 12 Months ] Adverse events, Serious adverse events and Dose limiting toxicities
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT03459469 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
1. To determine the durability of response (DOR) to BC2059 after the achievement of best response [ Time Frame: 12 Months ] Assessing CR and PR
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059 | ||||
Official Title ICMJE | Phase 1 Trial of BC2059 (Tegavivint) in Patients With Unresectable Desmoid Tumor | ||||
Brief Summary | Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive. | ||||
Detailed Description | This study is a phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive. This study will utilize single patient cohorts for the first two dose levels in order to minimize sub-optimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD or RP2D determined by pharmacokinetics or biologically relevant activity. Once MTD or RP2D is determined, that dose level cohort will expand to 14 patients enrolled to collect additional safety PK and PD data. If at least 1 patient has clinical benefit, the dose expansion phase will be expanded by a further 11 patients (25 total in at RP2D). The total duration of study for each subject will be dependent upon the safety, tolerability and efficacy of BC2059 | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Desmoid Tumor | ||||
Intervention ICMJE | Drug: Tegavivint
This is an Investigational drug
Other Name: BC2059 |
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Study Arms | Experimental: Investigational drug
An open-label, non-randomized study to evaluate safety of Tegavivint administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.
Intervention: Drug: Tegavivint |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | November 1, 2019 | ||||
Estimated Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03459469 | ||||
Other Study ID Numbers ICMJE | BCI-001-DT17 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Beta Cat Pharmaceuticals, Inc. | ||||
Study Sponsor ICMJE | Beta Cat Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Beta Cat Pharmaceuticals, Inc. | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |