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Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC)

NCT02447887 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-09-26

Study results available
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Summary

This is a Phase I/II trial of the combination pegylated IFN-alpha 2b with ixazomib in metastatic renal cell carcinoma (mRCC). Researchers believe that by disabling the protein complex NF-kB, which controls the transfer of genetic information; using the study drug Ixazomib, they can promote necrotic cell death of RCC using interferon alpha - 2b. They hypothesize that the combination of ixazomib with IFN will lead to increased necrotic cell death in RCC tumors and consequent clinical benefit to patients.

Patients will receive ixazomib capsules and pegylated IFN alfa 2b injection in this research study. Treatments will be given weekly and 4 weeks of treatment make up one cycle.

Conditions

  • Metastatic Renal Cell Carcinoma
  • RCC

Interventions

DRUG

Ixazomib

The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).

DRUG

Pegylated IFN-alpha 2b

Weekly injection

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-14
Primary Completion
2017-04-25
Completion
2017-04-25

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 NCT02447887 on ClinicalTrials.gov