Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. FDA label
Also known as Vandetanib (ZD6474), Vandetanib (SAR390530), SAR390530, Zactima TM, Zactima, ZD6474, AZ6474
vandetanib · 35 trials · 35 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 to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.
Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).
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.
Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
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)
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE.
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
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
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
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 | - |
| A | EXPERIMENTAL | Vandetanib 300 mg as a once daily oral dose, from Day 1 |
| B | EXPERIMENTAL | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy) |
| C | PLACEBO_COMPARATOR | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy). |
| vandetanib (ZD6474) | EXPERIMENTAL | vandetanib (ZD6474) 300 mg per os once daily |
| 3 | EXPERIMENTAL | Best Supportive Care + ZD6474 300 mg |
| ZD6474 100mg | EXPERIMENTAL | Daily dose |
| ZD6474 200mg | EXPERIMENTAL | daily dose |
| ZD6474 300mg | EXPERIMENTAL | daily dose |
| Caprelsa (vandetanib) 300 mg | EXPERIMENTAL | Daily oral dose of Caprelsa (vandetanib) 300mg |
| Vandetanib 300mg | EXPERIMENTAL | 300 mg/day 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 |
| ZD6474 (vandetanib) 100mg | EXPERIMENTAL | - |
| ZD6474 (vandetanib) 300mg | EXPERIMENTAL | - |
| 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 |
| ZD6474 (Vandetanib) | DRUG | once daily oral tablet |
| Best Supportive Care | OTHER | standard of care |
| Erlotinib | DRUG | oral dose |
| ZD6474, Vandetanib | DRUG | 300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Gemcitabine | DRUG | administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo matching ZD6474 | DRUG | Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo to Match ZD6474, Vandetanib | DRUG | 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Bicalutamide | DRUG | 150mg orally, once daily |
| FOLFIRI | DRUG | Intravenous infusion |
| FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid | DRUG | intravenous infusion |
| Vandetanib (ZD6474) | DRUG | once daily oral dose |
| Docetaxel | DRUG | intravenous infusion |
| Zactima (vandetanib) | DRUG | - |
| Prednisolone | DRUG | - |
| ZD6474 (vandetanib) 100mg | DRUG | once daily oral dose |
| ZD6474 (vandetanib) 200mg | DRUG | once daily oral dose |
| ZD6474 (vandetanib) 300mg | DRUG | once daily oral dose |
| ZD6474 | DRUG | - |
| Paclitaxel | DRUG | - |
| Carboplatin | DRUG | - |
| adjuvant therapy | PROCEDURE | - |
| ZD1839 | DRUG | - |
| VEGF-receptor tyrosine kinase (KDR) | DRUG | - |
| Vandetanib 300mg | DRUG | 300 mg oral dose once daily (100 mg x 3 tablets) |
| omeprazole | DRUG | Oral capsules, 40 mg, multiple doses |
| ranitidine | DRUG | Oral tables, 150 mg, multiple doses |
| Cisplatin | DRUG | intravenous infusion |
| Radiation | RADIATION | radiation of head and neck |
| Vandetanib 300 mg | DRUG | 300mg once daily |
| Zactima (ZD6474) | DRUG | - |
| Vinorelbine plus cisplatin | DRUG | - |
| Gemcitabine plus cisplatin | DRUG | - |
| ZD6474 (Zactima) 100mg | DRUG | - |
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR) | PROCEDURE | - |
| Biomarker Draws | PROCEDURE | - |
| ZD6474 (Zactima) 300mg | DRUG | - |
| 5-Fluorouracil | DRUG | intravenous infusion |
| Leucovorin | DRUG | intravenous infusion |
| Oxaliplatin | DRUG | intravenous infusion |
| Irinotecan | DRUG | intravenous infusion |
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 a small molecule oncology drug developed by Sanofi. It is an inhibitor that targets EPHA2, EPHB2, EPHA5, EPHA4, EPHA8, and EPHA6. It has been studied in advanced breast cancer, advanced solid tumors, malignant tumors, hepatocellular carcinoma, colorectal cancer, and differentiated thyroid cancer.
Vandetanib has been studied for the treatment of several cancer types, including differentiated thyroid cancer, medullary thyroid carcinoma, advanced breast cancer, advanced solid tumors, malignant tumors, hepatocellular carcinoma, and colorectal cancer. It is an investigational agent in clinical development rather than a confirmed approved therapy for these indications.
Vandetanib targets the ephrin receptors EPHA2, EPHB2, EPHA5, EPHA4, EPHA8, and EPHA6. It is classified as an inhibitor of these molecular targets. This receptor targeting is the basis for its investigation as an oncology therapeutic across solid tumor and thyroid cancer settings.
Vandetanib is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the clinical development program for this small molecule oncology candidate across the studied cancer indications.
Vandetanib is in Phase 2 development overall, with additional trials conducted at Phase 3 and Phase 1. It is an investigational drug still in clinical development and is not presented as an approved product. Its trial program includes completed studies in thyroid cancer and other solid tumors.
Vandetanib has been evaluated in completed trials including NCT01876784, a Phase 3 study in differentiated thyroid cancer with 238 patients, NCT01298323, a Phase 3 study in medullary thyroid cancer with 205 patients, and NCT01661179, a Phase 1 study in Japanese patients with medullary thyroid carcinoma. NCT01539655 was a Phase 1 pharmacokinetic study in healthy volunteers.
Yes. Vandetanib is also known as ZD6474 and SAR390530, and it has been referenced as vandetanib 800 mg and vandetanib 300 mg in study contexts. These names refer to the same small molecule compound developed by Sanofi, so searches for ZD6474 or SAR390530 lead to the same drug asset.