Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
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ClinicalTrials.gov Identifier: NCT01991938 |
Recruitment Status :
Terminated
(Lack of recruitment and the company's decision to de-prioritize 5584 development)
First Posted : November 25, 2013
Last Update Posted : January 27, 2017
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Sponsor:
Verastem, Inc.
Information provided by (Responsible Party):
Verastem, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | November 18, 2013 | |||
First Posted Date ICMJE | November 25, 2013 | |||
Last Update Posted Date | January 27, 2017 | |||
Study Start Date ICMJE | November 2013 | |||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Assess the pharmacokinetics of VS-5584 [ Time Frame: Time points on Day 1, 2, 3, 17, 18 ] PK (pharmacokinetics) parameters, including but not limited to plasma concentration, clearance, AUC (Area Under Curve, 0-24 and 0-t), Cmax, Tmax, and T1/2
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma | |||
Official Title ICMJE | A Phase I Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma | |||
Brief Summary | This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: VS-5584 | |||
Study Arms ICMJE | Experimental: VS-5584
Oral VS-5584 administered once daily on Day 1, 3, 5, 8, 10, 12, 15, 17 and 19 of each cycle
Intervention: Drug: VS-5584
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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 | Terminated | |||
Actual Enrollment ICMJE |
75 | |||
Original Estimated Enrollment ICMJE |
62 | |||
Actual Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01991938 | |||
Other Study ID Numbers ICMJE | VS-5584-101 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Verastem, Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Verastem, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Verastem, Inc. | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |