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Pazopanib + interferon alpha 2A

Phase 1

Advanced Renal Cell Carcinoma | Small molecule | Oncology |GSK plc|Last Updated: Mar 10, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01513187Pazopanib in Combination With Interferon Alfa 2-A, in Patients With Advanced Renal Cell CarcinomaPHASE1 COMPLETED 53Jul 11, 2011Feb 22, 2019Mar 10, 202213 Spain
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Study Endpoints
Primary Endpoints
Maximum tolerated dose (MTD) - Phase I
Up to September 2012

The MTD is defined as the dose at wich two of the patients have experienced dose-limiting toxicity.

Efficacy, response rate (Phase II)
Up to July 2013

Response rate is defined as the percentage of patients with complete response or partial response confirmed according RECIST v.1.1

Secondary Endpoints
Progression free survival
Up to July 2013
Overall Survival
Up to December 2013
Frequency of adverse events
Up to July 2013
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pazopanib + interferonEXPERIMENTALFive levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days. Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient
Interventions
NameTypeDescription
Pazopanib + interferon alpha 2ADRUGFive levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days. Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Signed informed consent 2. Age ≥ 18 years. 3. Patients diagnosed histologically clear cell carcinoma of the kidney metastatic or unresectable locally advanced, previously untreated. However, in Phase I may include patients with primary tumors other than renal cell can benefit...

Countries:Spain
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