Spots Global Cancer Trial Database for Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma
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Trial Identification
Brief Title: Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma
Official Title: A Phase I Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma
Study ID: NCT03422874
Study Description
Brief Summary: This is an open label, dose escalation, phase I study of the combination of MLN9708 plus Nelfinavir.
Detailed Description: This is an open label, dose escalation, phase I study of the combination of MLN9708 MLN9708 plus Nelfinavir. It will use a 3+3 cohort design to determine the maximum tolerated dose of the combination, which will be defined as the highest dose cohort where \< 1/6 patients develop a dose limiting toxicity. The maximum tolerated dose cohort will be expanded to have at least 6 patients with biopsiable tumors who undergo pretreatment and post treatment tumor biopsies for molecular pharmacodynamic markers.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Contact Details
Name: Lionel D Lewis, MD
Affiliation: Dartmouth-Hitchcock Medical Center
Role: PRINCIPAL_INVESTIGATOR
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