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

NCT03422874 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-02-06

No results posted yet for this study

Summary

This is an open label, dose escalation, phase I study of the combination of MLN9708 plus Nelfinavir.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Lionel D Lewis, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-08-04
Completion
2017-08-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422874 on ClinicalTrials.gov