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recombinant interleukin-21

Phase 2

Cancer | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Aug 14, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials3
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00523380Efficacy Study of Recombinant Interleukin-21 in the Treatment of Ovarian CancerPHASE2 COMPLETED 10Oct 4, 2007Jan 7, 2009Mar 1, 20177 France, Germany
NCT00617253Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma PatientsPHASE2 COMPLETED 9Jul 12, 2007Jun 30, 2008Mar 1, 20175 Germany, Netherlands
NCT00336986Efficacy Study of IL-21 to Treat Metastatic MelanomaPHASE2 COMPLETED 54Sep 1, 2004Oct 1, 2007Aug 14, 20237 Australia
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Study Endpoints
Primary Endpoints
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
after max. 6 treatment cycles
Toxicity according to CTCAE version 3.0
For the duration of the trial
Tumor size assessed according to international criteria
After 8 weeks
Secondary Endpoints
Pharmacokinetics
Initially
IL-21 antibody formation
For the duration of the trial
Progression free survival
For the duration of the trial
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DEXPERIMENTAL -
Interventions
NameTypeDescription
recombinant interleukin-21DRUGAdministered i.v. in treatment cycles of 28 days.
caelyx (pegylated liposomal doxorubicin)DRUGAdministered i.v. in treatment cycles of 28 days.
sunitinibDRUGHard gelatine capsules, 12.5 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria...

Countries:FranceGermanyNetherlandsAustralia
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