Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
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|ClinicalTrials.gov Identifier: NCT03808558|
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|KRAS Gene Mutation||Drug: TVB-2640||Phase 2|
Patients with stable disease or partial/complete remissions will continue therapy.
The endpoints are response rate-RR, disease control rate-DCR, PFS-progression-free survival, CTCAEv5.0 toxicities, plasma lipid levels, collection of sebaceous secretion via Sebutape, and 11C-acetate PET tumor imaging.
In the first stage, 13 patients will be enrolled. If fewer than 2 patients achieve response, the study will be stopped. If 2 or more patients have a radiographic response, an additional 21 patients will be enrolled , for a total accrual of 34 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multi-center Pharmacodynamics Study of TVB-2640 in KRAS Mutant Non-small Cell Lung Carcinomas|
|Actual Study Start Date :||September 11, 2019|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
- Disease control rate of TVB-2640 [ Time Frame: every 8 weeks through study completion, an average of 1 year ]Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile.
- Response rate of TVB-2640 [ Time Frame: every 8 weeks through study completion, an average of 1 year ]Determine response rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile.
- Safety profile of TVB-2640 [ Time Frame: Pretreatment and four weeks of treatment. ]Secondary endpoints are 11C-acetate tumor uptake pretreatment and at four weeks of treatment and plasma lipidomics pretreatment and at four weeks of treatment.
- Establish the predictive value of 11C-acetate PET [ Time Frame: Pretreatment and four weeks of treatment. ]To establish the predictive value of 11C-acetate PET pretreatment and post-treatment tumor uptake for disease control rate and response rate
- Mean change in fasting plasma lipidomics [ Time Frame: Pretreatment and four weeks of treatment. ]Blood samples for fasting plasma lipidomics will be collected at baseline and four weeks of treatment.
- Mean change in sebaceous secretion of fatty acids [ Time Frame: Pretreatment and four weeks of treatment. ]Sebutabe collection of sebaceous secretion of fatty acids will be performed at baseline and four weeks of treatment
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): NCT03808558
|Contact: Jeffery Wilson||214-648-7097||Jeffery.Wilson@utsouthwestern.edu|
|Contact: David Gerber, MDemail@example.com|
|United States, Ohio|
|University of Cincinnati||Not yet recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Muhammad Riaz, MD 513-584-7698 Riazmk@ucmail.uc.edu|
|Contact: Christine Vollmer, MBA firstname.lastname@example.org email@example.com|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-9179|
|Contact: David Gerber, MD 214-648-4180 David.Gerber@utsouthwestern.edu|
|Principal Investigator: David Gerber, MD|
|Principal Investigator:||David Gerber, MD||Professor|