NCT03422874

Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma

A Phase I Dose Escalation Study of Nelfinavir Plus MLN9708 in Patients With Advanced Solid Tumors or Lymphoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• Lymphoma

Interventions

Type	Name	Description
DRUG	MLN9708	MLN9708 is a second-generation reversible proteasome inhibitor which shows greater oral bioavailability, improved pharmacokinetics and enhanced antitumor activity compared with bortezomib (VELCADE®).
DRUG	Nelfinavir	Nelfinavir is an oral HIV protease inhibitor approved by FDA in 1997, now available in generic form. It has a well established safety profile in HIV patients when administered at the recommended dose of 1250 mg PO BID. Nelfinavir was shown to induce ER stress in cancer cell lines and xenograft tumors leading to apoptosis and tumor growth inhibition.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-04
• Completion: 2017-08-04
• First posted: 2018-02-06
• Last updated: 2018-02-06

Locations

1 site across 1 country: United States