Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC)
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|ClinicalTrials.gov Identifier: NCT02447887|
Recruitment Status : Terminated (IRB study closure facilitated by Investigator)
First Posted : May 19, 2015
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma RCC||Drug: Ixazomib Drug: Pegylated IFN-alpha 2b||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC)|
|Actual Study Start Date :||August 14, 2015|
|Actual Primary Completion Date :||April 25, 2017|
|Actual Study Completion Date :||April 25, 2017|
Experimental: Ixazomib and pegylated IFN alfa - 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.
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
Other Name: pIFN - alpha 2b
- Non-hematologic Toxicity ≥ Grade 3 Per CTCAE v4 Except: [ Time Frame: 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 [ Time Frame: Up to week 8 ]
- Grade 4 Neutropenia Per CTCAE v4; Associated With Fever or Hospitalization for Infection [ Time Frame: Up to week 8 ]
- Grade 4 Neutropenia Per CTCAE v4; Lasting Longer Than 5 Days [ Time Frame: 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. [ Time Frame: 28 Days ]
- 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. [ Time Frame: 28 Days ]
- Progression Free Survival Per RECIST 1.1 [ Time Frame: At week 8 ]
- Progression Free Survuval Per RECIST 1.1 [ Time Frame: At week 16 ]
- Overall Response Rate [ Time Frame: Week 8 ]
- Overall Response Rate [ Time Frame: Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447887
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|