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

Phase 1

Terminated

• Conditions: Metastatic Renal Cell Carcinoma; RCC
• Interventions: Drug: Ixazomib; Drug: Pegylated IFN-alpha 2b

• Registration Number: NCT02447887
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Study Start: 2015-08-14
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Status Verified: 2019-09
• Results First Submitted: 2019-09-04
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-09-26
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ixazomib and pegylated IFN alfa - 2b	Pegylated IFN-alpha 2b	Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.
Ixazomib and pegylated IFN alfa - 2b	Ixazomib	Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Per RECIST 1.1	At week 8
Any Unacceptable Toxicity (UT) Defined as Any CTCAE v4 Grade 5 Toxicity, Grade 4 Neuropsychiatric Toxicity or Grade 4 Clinically Significant Non-hematologic Toxicity Thought to be Definitely, Probably or Possibly Related to Study Drug.	28 Days
Non-hematologic Toxicity ≥ Grade 3 Per CTCAE v4 Except:	Up to week 8	* Grade 3 nausea or Grade 3 vomiting ≤ 72 hours that recovers to grade 0-2 with maximal antiemetic therapy.; * Grade 3 diarrhea that resolves to grade 0-2 with loperamide or diphenoxylate/atropine within 48 hours.; * Grade 3 hypercholesterolemia, hypertriglyceridemia, hyperglycemia or hypophosphatemia that resolves to grade 0-2 with medical management.; * Transient electrolyte abnormalities lasting ≤ 1 week.
Thrombocytopenia ≥ Grade 3 Per CTCAE v4	Up to week 8
Grade 4 Neutropenia Per CTCAE v4; Associated With Fever or Hospitalization for Infection	Up to week 8
Grade 4 Neutropenia Per CTCAE v4; Lasting Longer Than 5 Days	Up to week 8
Any Toxicity Felt at the Investigator's Discretion to be Possibly or Probably Related to Ixazomib That Causes the Patient to Miss More Than 1 Dose of Either Ixazomib or pIFN in the First 28 Days.	28 Days
Progression Free Survuval Per RECIST 1.1	At week 16

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Week 16

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States