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Proteasome Inhibitor

Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan for Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Susanne M Arnold, MD
Research Sponsored by Cancer Research and Biostatistics Clinical Trials Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

The purpose of this study is to determine a well-tolerated dose of Carfilzomib in combination with Irinotecan (Phase 1b portion of the study) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers and to assess the 6 month survival of relapsed small cell lung cancer patients treated with this combination therapy. **The Phase 1b portion of the study is now complete**. Phase 2 portion of the study. The safest, maximally tolerated dose established as established in Phase 1 for Phase 2 is as follows -- Carfilzomib will be provided at 20/36 mg/m^2 with Irinotecan dosed at 125 mg/m^2. The purpose of the Phase 2 portion of the study is to assess 6 month survival of relapsed small cell lung cancer ins subjects treated with this combination therapy.

Eligible Conditions
  • Cancer
  • Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II: Overall Survival Rate at 6 Months
Phase Ib: Maximum Tolerated Dose
Secondary outcome measures
Overall Response Rate
Phase II: Progression-Free Survival Rate at 6 Months
Phase Ib: Dose Limiting Toxicities

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 IrinotecanExperimental Treatment2 Interventions
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 2 used a starting dose of 20/36 mg/m^2 of carfilzomib in combination with 125 mg/m^2 of irinotecan.
Group II: Phase Ib Cohort 1: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 IrinotecanExperimental Treatment2 Interventions
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 3 used a starting dose of 20/45 mg/m^2 of carfilzomib in combination with 125 mg/m^2 of irinotecan.
Group III: Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 IrinotecanExperimental Treatment2 Interventions
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Cohort 1 used a starting dose of 20/27 mg/m^2 of carfilzomib in combination with 125 mg/m^2 of irinotecan.
Group IV: Phase IIExperimental Treatment2 Interventions
Phase II: Stratified, single arm trial using a starting dose of 20/36 mg/m^2 of carfilzomib and 125 mg/m^2 of irinotecan, in small cell lung cancer patients who have relapsed on a prior platinum regimen. Stratification for phase II component: Platinum sensitive disease: initial response to platinum-based chemotherapy with progression > 90 days after last treatment. Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Irinotecan
FDA approved

Find a Location

Who is running the clinical trial?

Cancer Research and Biostatistics Clinical Trials ConsortiumLead Sponsor
2 Previous Clinical Trials
38 Total Patients Enrolled
Lucille P. Markey Cancer Center at University of KentuckyOTHER
3 Previous Clinical Trials
420 Total Patients Enrolled
Washington University School of MedicineOTHER
1,942 Previous Clinical Trials
2,304,217 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients
2013. "Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01941316.
~7 spots leftby May 2025
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