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Zactima

Phase 2

Prostate Cancer | Small molecule | Oncology |Sanofi|Last Updated: Oct 7, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

Zactima · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT00498797E3-Hormone Refractory Prostrate Cancer Taxotere CombinationProstate Cancer
COMPLETED86 Analytics
PHASE2COMPLETED
E3-Hormone Refractory Prostrate Cancer Taxotere Combination
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Prostate Specific Antigen (PSA) Response
PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline

Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response

Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary Endpoints

Number of Patients With an Objective Disease Progression Event
RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)
Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered
Predetermined timepoints after dose administration
Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Zactima (vandetanib)DRUG -
DocetaxelDRUG -
PrednisoloneDRUG -
Zactima (ZD6474)DRUG -
Vinorelbine plus cisplatinDRUG -
Gemcitabine plus cisplatinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA * No previous chemotherapy although those patients that have received estramustine can ...

Countries:BrazilGermanyHungarySouth AfricaSweden
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Zactima

What is Zactima used for?

Zactima is an investigational small molecule being developed for oncology indications, specifically non-small cell lung cancer and prostate cancer. It has been studied in clinical trials for these conditions, including a Phase 1 trial in locally advanced or metastatic non-small cell lung cancer and a Phase 2 trial in metastatic hormone-refractory prostate cancer.

Who makes Zactima?

Zactima is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is responsible for the clinical development of this investigational oncology drug.

What phase is Zactima in?

Zactima is in clinical development, with completed trials including a Phase 1 study and a Phase 2 study. The drug is investigational and has not been approved by regulatory authorities. Its development status is based on the completed clinical trials for non-small cell lung cancer and prostate cancer.

What clinical trials is Zactima in?

Zactima has been studied in two completed clinical trials. NCT00496275 was a Phase 1 combination trial with vinorelbine or gemcitabine plus cisplatin in locally advanced or metastatic non-small cell lung cancer, enrolling 17 participants. NCT00498797 was a Phase 2 trial combining Zactima with Taxotere in metastatic hormone-refractory prostate cancer, enrolling 86 participants.

How does Zactima work?

Zactima is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here. It is being investigated for its potential role in treating non-small cell lung cancer and prostate cancer.