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A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02223247
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
3V Biosciences, Inc.

Brief Summary:
This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced stage solid malignant tumors. This research is being done to find out how safe and useful TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy exists that would be curative or might provide significant benefit. TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they interfere with the body's (and the tumor's) ability to use a substance called fatty acid synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.

Condition or disease Intervention/treatment Phase
Solid Malignant Tumor Drug: TVB-2640 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
Study Start Date : November 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: TVB-2640
Oral TVB-2640 capsules or tablets of various dose strengths administered QD for 21 - 28 day dosing cycles, alone or in combination with certain standard chemotherapy agents
Drug: TVB-2640



Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) based on toxicity analysis. [ Time Frame: 1.5 years ]
    Toxicity will be monitored according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). Patients receiving at least one dose of drug.

  2. To determine the incidence and nature of dose-limiting toxicities (DLTs) of TVB-2640. [ Time Frame: Days 1 to 21 of cycle 1 for monotherapy cohort(s); Days 1 to 28 of cycle 1 for combination with anti-cancer agent cohort(s) ]

Secondary Outcome Measures :
  1. Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). [ Time Frame: Up to 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first. ]
  2. Pharmacokinetic parameters of TVB-2640 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state) [ Time Frame: At Cycle Day 1, 2, 8, 15, (and 22 for combination cohorts) then the first day of subsequent cycles until discontinuation. ]
    Cmax, Cmin, Tmax, AUC and Half-life of TVB-2640

  3. Tumor response per RECIST 1.1 [ Time Frame: Measured every 6 weeks for 21 day cycles or every 8 weeks for 28 day cycles for the duration of study treatment, estimated to be less than one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Include:

  • Patient has histologically- or cytologically- confirmed metastatic or advanced-stage solid malignant tumor that is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit and therefore for whom experimental therapy is a reasonable option.
  • Patient experienced progressive disease during or following or was intolerant of their most recent treatment regimen.
  • Patient is male or female aged ≥18 years.
  • Patient has an ECOG performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), as assessed on C1D1, before the first dose of TVB 2640.
  • Patient has adequate renal function (creatinine ≤1.5 times the upper limit of normal [ULN]) or a glomerular filtration rate (GFR) of ≥50 mL/min.
  • Patient has adequate hepatic function,
  • Patient has adequate bone marrow function
  • Patient has no significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of TVB 2640 and currently has adequate cardiac function

For the Monotherapy Expansion Cohorts of the Study ONLY:

  • Patient has a specific tumor-type and histology, as designated by the Sponsor based on nonclinical and clinical data obtained prior to enrollment in the Expansion Cohort.
  • Patient has measurable disease, as determined by the Investigator using RECIST, version 1.1 (1).

For the Combination Cohorts ONLY:

  • In addition to meeting monotherapy criteria above, the commercially-available anticancer agent of interest being investigated in combination with TVB-2640, administered according to the dose regimen in the prescribing information, is deemed appropriate for the patient's disease and clinical status.

Exclusion Criteria Include:

  • Patient is unable to swallow oral medications or has impairment of GI function or GI disease that may significantly alter drug absorption
  • Patient has uncontrolled or severe intercurrent medical condition (including uncontrolled brain metastases).
  • Patient underwent major surgery within 4 weeks before the first dose of TVB 2640 or received cancer-directed therapy or an investigational drug or device within 4 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is shorter) before the first dose of TVB 2640.
  • If female, patient is pregnant or breast-feeding.
  • Patient has evidence of a serious active infection
  • Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.

Information from the National Library of Medicine

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): NCT02223247


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Sarasota, Florida, United States, 34232
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75390
San Antonio, Texas, United States, 78229
United Kingdom
Charthouse Square, London, United Kingdom
London, United Kingdom, W1G 6AD
Manchester, United Kingdom
West Smithfield, London, United Kingdom
Sponsors and Collaborators
3V Biosciences, Inc.
Investigators
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Principal Investigator: Jeffrey R Infante, MD The Sarah Cannon Research Institute

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Responsible Party: 3V Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02223247     History of Changes
Other Study ID Numbers: 3V2640-CLIN-002
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by 3V Biosciences, Inc.:
solid tumors
cancer

Additional relevant MeSH terms:
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Neoplasms