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CP-675,206 and gemcitabine

Phase 1

Pancreatic Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 6, 2012

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 Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00556023A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic CancerPHASE1 COMPLETED 37Jun 1, 2008Aug 1, 2011Jun 6, 20125 Canada, Italy
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicities: assessed through adverse event data collected weekly
8 week intervals
Secondary Endpoints
HAHA Response to CP-675,206:
12 months
Lymphocyte Subset Analysis:
12 months
Cytokine Analysis:
12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CP-675,206 and gemcitabineEXPERIMENTAL -
Interventions
NameTypeDescription
CP-675,206 and gemcitabineDRUGEscalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients with metastatic pancreatic cancer * Patient must have adequate bone marrow, liver and kidney function * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 * Chemotherapy naive * Inoperable pancreatic cancer Exclusion Criteria: ...

Countries:CanadaItaly
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Competitive Landscape -Pancreatic Cancer 186 trials
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AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine, Telisotuzumab adizutecan, Fluorouracil, Folinic acid/ Leucovorina
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Agenus Inc.AGEN5PHASE2Botensilimab, Gemcitabine, Nab-paclitaxel, AGEN1423, Balstilimab
Eli Lilly and CompanyLLY7PHASE1LY4101174, LY4066434., Cetuximab, Nab paclitaxel, Gemcitabine
Merck & Co., Inc.MRK2PHASE2Belzutifan, Sacituzumab tirumotecan, Fluorouracil, Leucovorin or levoleucovorin, Cisplatin
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822, MRG007, JAB-3312
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
ImmunityBio IncIBRX2PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Candel Therapeutics, Inc.CADL1PHASE2Aglatimagene besadenovec
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pemigatinib, Retifanlimab
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