Clinical trial · Interventional
An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment stopped according to early stopping rule (by protocol)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vandetanib | Drug | Vandetanib | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Vinorelbine
- interventionNames
- Drug: Vinorelbine
- type
- EXPERIMENTAL
- label
- 2
- description
- Vandetanib
- interventionNames
- Drug: Vandetanib
Primary outcomes (1)
- measure
- Number of Participants With Disease Control.
- timeFrame
- Assessed at 2 months.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available