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Caprelsa

Phase 2

Pancreatic Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 13, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

Caprelsa · 1 trial · 1 indication

Phase 2 1
NCT01601808Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic CarcinomaPancreatic Cancer
COMPLETED142 Analytics
PHASE2COMPLETED
Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation

To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer

Secondary Endpoints

Progression-free survival time
Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Objective response rate
Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
Disease control rate
Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Gemcitabine and PlaceboPLACEBO_COMPARATORStandard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.
Gemcitabine and vandetanibEXPERIMENTALExperimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.

Interventions

NameTypeDescription
PlaceboDRUGOrally once a day, continuously throughout the study
Caprelsa (vandetanib)DRUGOrally once a daily, continuously throughout the study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Age ≥ 18 years. * Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas. * Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radia...

Countries:United Kingdom
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Competitive Landscape -Pancreatic Cancer 179 trials

Top 20 of 68 competitors

CompanyTickerTrialsLead PhaseDrugs
Revolution Medicines, Inc.RVMD9PHASE3RMC-6236, Gemcitabine, nab-paclitaxel, Irinotecan, Liposomal irinotecan
Arcus Biosciences, Inc.RCUS3PHASE3Quemliclustat, Nab-paclitaxel, Gemcitabine
Pfizer Inc.PFE7PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
AstraZeneca PLCAZN9PHASE2AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
AbbVie, Inc.ABBV4PHASE2TTX-030, nab-paclitaxel and gemcitabine, Nab-Paclitaxel and gemcitabine
AngioDynamics, Inc.ANGO2PHASE3Modified FOLFIRINOX Regimen
Bristol-Myers Squibb CompanyBMY4PHASE2Navlimetostat, Gemcitabine, Nab-paclitaxel
Immuneering Corp. Class AIMRX2PHASE3Atebimetinib, GnP, mGnP
RenovoRx, Inc.RNXT1PHASE3Gemcitabine, nab-paclitaxel
BioNTech SE Sponsored ADRBNTX2PHASE2Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX
Veracyte, Inc.VCYT1PHASE3Tislelizumab
ArriVent BioPharma, Inc.AVBP3PHASE2JAB-21822
Merck & Co., Inc.MRK2PHASE2Belzutifan
Eli Lilly and CompanyLLY7PHASE1LY4101174
Exelixis, Inc.EXEL1PHASE2Zanzalintinib, Everolimus
Agenus Inc.AGEN4PHASE2AGEN1423, Botensilimab, Gemcitabine, Nab-paclitaxel
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
Incyte CorporationINCY3PHASE2Ruxolitinib, Capecitabine, Regorafenib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
ImmunityBio IncIBRX1PHASE2N-803, Aldoxorubicin, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
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Frequently asked questions about Caprelsa

What is Caprelsa used for in pancreatic cancer?

Caprelsa is a small molecule being studied for the treatment of pancreatic cancer. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in combination with gemcitabine compared to gemcitabine alone in patients with pancreatic carcinoma.

What does Caprelsa target?

Caprelsa, also known as vandetanib, is a small molecule that targets multiple receptor tyrosine kinases. It inhibits vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) tyrosine kinase activity, which are involved in tumor growth and angiogenesis.

Who makes Caprelsa?

Caprelsa is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in pancreatic cancer.

What phase is Caprelsa in?

Caprelsa is in Phase 2 clinical development for pancreatic cancer. It is an investigational drug and has not been approved by regulatory authorities for this indication. The Phase 2 trial has been completed, and the drug is no longer in active clinical trials for this condition.

What clinical trials is Caprelsa in?

Caprelsa has been studied in one completed Phase 2 clinical trial with the identifier NCT01601808. This randomized, double-blind, placebo-controlled trial enrolled 142 participants and compared gemcitabine plus vandetanib therapy with gemcitabine alone in patients with pancreatic carcinoma. The trial was conducted in the United Kingdom.

Is Caprelsa the same as vandetanib?

Yes, Caprelsa is the brand name for vandetanib. In clinical trials, the drug is referred to as vandetanib, and Caprelsa is the proprietary name used by the developer. Both names refer to the same small molecule being investigated for pancreatic cancer.