Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vandetanib · 19 trials · 18 indications
The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Median time (in weeks) from randomization until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
modified RECIST V1.0 was used.
Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for \>=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST). Complete Response - Disappearance of all target lesions; Partial Response - \>=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - \>=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.
| Arm | Type | Description |
|---|---|---|
| Vandetanib/ Vandetanib | EXPERIMENTAL | Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months. |
| Placebo/ Vandetanib | PLACEBO_COMPARATOR | Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months. |
| Vandetanib Control | ACTIVE_COMPARATOR | Control - treatment 300mg vandetanib opel label |
| Experimental | EXPERIMENTAL | Experimental - treatment 300mg vandetanib opel label |
| 1 | PLACEBO_COMPARATOR | Placebo Vandetanib + Pemetrexed |
| 2 | EXPERIMENTAL | Vandetanib + Pemetrexed |
| Vandetanib | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| vandetanib (ZD6474) | EXPERIMENTAL | vandetanib (ZD6474) 300 mg per os once daily |
| 3 | EXPERIMENTAL | Best Supportive Care + ZD6474 300 mg |
| Vandetanib 300mg | EXPERIMENTAL | 300 mg/day vandetanib |
| midazolam then midazolam + vandetanib | EXPERIMENTAL | Midazolam alone followed by midazolam in combination with vandetanib |
| digoxin then digoxin + vandetanib | EXPERIMENTAL | Digoxin alone followed by digoxin in combination with vandetanib |
| Metformin then metformin + vandetanib | EXPERIMENTAL | Metformin alone followed by metformin in combination with vandetanib |
| vandetanib then vandetanib + omeprazole | EXPERIMENTAL | Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 |
| vandetanib + omeprazole then vandetanib | EXPERIMENTAL | Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 |
| vandetanib then vandetanib + ranitidine | EXPERIMENTAL | Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2 |
| vandetanib + ranitidine then vandetanib | EXPERIMENTAL | Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 |
| 100 mg Vandetanib eod | EXPERIMENTAL | 100 mg Vandetanib every other day dosing |
| 100 mg Vandetanib od | EXPERIMENTAL | 100 mg Vandetanib once daily dosing |
| 300 mg Vandetanib od | EXPERIMENTAL | 300 mg Vandetanib once daily dosing |
| Dose level 1 | ACTIVE_COMPARATOR | Vandetanib 100mg/day plus Gemcitabine |
| Dose level 2 | ACTIVE_COMPARATOR | Vandetanib 300mg/day plus Gemcitabine |
| Dose level 3 | ACTIVE_COMPARATOR | Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose |
| Dose level 4 | ACTIVE_COMPARATOR | Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose |
| Name | Type | Description |
|---|---|---|
| Vandetanib (SAR390530) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Patient outreach | BEHAVIORAL | Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner |
| Vandetanib | DRUG | Treatment 300mg vandetanib opel label. |
| Pemetrexed | DRUG | intravenous infusion |
| Erlotinib | DRUG | oral dose |
| Docetaxel | DRUG | infusion |
| Best Supportive Care | DRUG | Placebo + Best Supportive Care |
| FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid | DRUG | intravenous infusion |
| FOLFIRI | DRUG | Intravenous infusion |
| Vandetanib (ZD6474) | DRUG | once daily oral dose |
| adjuvant therapy | PROCEDURE | - |
| Vandetanib 300mg | DRUG | 300 mg oral dose once daily (100 mg x 3 tablets) |
| Midazolam | DRUG | Oral syrup 7.5 mg, single dose |
| Digoxin | DRUG | Oral tablets 0.25mg, single dose |
| Metformin 1000 mg | DRUG | 2 x 500 mg oral tablets |
| Vandetanib 800 mg | DRUG | 2 x 300 mg and 2 x 100 mg oral tablets |
| omeprazole | DRUG | Oral capsules, 40 mg, multiple doses |
| ranitidine | DRUG | Oral tables, 150 mg, multiple doses |
| Vandetanib 300 mg | DRUG | 300mg once daily |
Inclusion Criteria: * Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumor biopsy. * Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced ...
Vandetanib is an investigational small molecule being studied for multiple oncology indications, including colorectal cancer, advanced solid malignant tumors, medullary thyroid cancer, advanced breast cancer, differentiated thyroid cancer, and unresectable locally advanced or metastatic medullary thyroid carcinoma. It is currently in Phase 2 clinical development.
Vandetanib is being developed by Sanofi, a company traded under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Vandetanib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its potential in treating several types of cancer.
Vandetanib has been studied in clinical trials including NCT00066313 for small cell lung cancer, NCT00418886 for non-small cell lung cancer, NCT00537095 for thyroid cancer, and NCT01551615 for healthy volunteers. These trials are completed.
Yes, Vandetanib is also known as ZD6474. Clinical trial records refer to the drug by both names, such as in the study titled 'ZD6474 in Treating Patients With Small Cell Lung Cancer'.