A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02223247|
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : August 14, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Solid Malignant Tumor||Drug: TVB-2640||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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) ]
- 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. ]
- 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
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
|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|
|Charthouse Square, London, United Kingdom|
|London, United Kingdom, W1G 6AD|
|Manchester, United Kingdom|
|West Smithfield, London, United Kingdom|
|Principal Investigator:||Jeffrey R Infante, MD||The Sarah Cannon Research Institute|
|Responsible Party:||Sagimet Biosciences Inc.|
|Other Study ID Numbers:||
|First Posted:||August 22, 2014 Key Record Dates|
|Last Update Posted:||August 14, 2017|
|Last Verified:||August 2017|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|