TriangleNCT00597116 · REGISTRY CONDITION SEARCH
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2016-10-10
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Diagnosed with mesothelioma * Previously treated with only one course of chemotherapy for mesothelioma * No previous treatment with vinorelbine * No serious heart problems within the last 3 months Exclusion Criteria: * Serious abnormal laboratory values * Severe or uncontrolled disease or condition as judged by the Investigator * Pregnant or breast-feeding women * Other cancers within the last 5 years * Major surgery or radiation therapy within 4 weeks prior to starting study therapy * Receipt of any investigational agents within 30 days prior to commencing study treatment.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Vinorelbine
- intervention Names
- Drug: Vinorelbine
- label
- 1
- type
- ACTIVE_COMPARATOR
- description
- Vandetanib
- intervention Names
- Drug: Vandetanib
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- name
- Vinorelbine
- other Names
- Navelbine®
- type
- DRUG
- arm Group Labels
- 2
- description
- once daily oral dose
- name
- Vandetanib
- other Names
- ZD6474
- ZACTIMA™
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 25
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.
- measure
- Number of Participants With Disease Control.
- time Frame
- Assessed at 2 months.
- secondary Outcomes
- description
- Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.
- measure
- Number of Participants With Objective Response.
- time Frame
- Assessed at 2 months.
- description
- Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.
- measure
- Progression-free Survival (PFS)
- time Frame
- Assessed from baseline to 12 months.
- measure
- Overall Survival (OS)
- time Frame
- Assessed from baseline to 12 months.
Full study description
- brief Summary
- A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- NCT00597116
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- source kind
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- source file sha256
- 0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
- payload sha256
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- payload
- clinical indication matching status
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- end exclusive
- true
- id
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- link basis
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- nct id
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- occurrences
- context exact
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- end
- 11
- exact text
- NCT00597116
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Malignant Mesothelioma
- query disease state id
- ds-malignant-mesothelioma
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
- source file sha256
- 0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
- source json pointer
- /studies/2/protocolSection/identificationModule/nctId
- source kind
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- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 5b8c89f4eeaa3fa8ecc0cdcfffb4a531aaa81022c068a64756fee7dab13b7cc4
Preserved source evidence · Not medical advice