Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Recentin™, Cediranib
AZD2171 · 28 trials · 34 indications
For patients with measurable disease at entry (at least one lesion that has a shortest diameter ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that: 1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days. 2. The patient has died from any cause. 3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
Number of months from randomisation to the date of death from any cause
The number of patients free of grade III-V gastrointestinal perforation or fistula during cediranib treatment. This is causally related to cediranib or the cediranib olaparib combination, during cediranib treatment until patient withdraws, dies or has been treated with cediranib for at least 18 weeks, and for 28 days following the last dose. The proportion will be calculated with an exact 95% confidence interval (CI) calculated using the Clopper-Pearson method.
The ORR was defined as the percentage of patients with objective response (complete response \[CR\] or partial response \[PR\]) according to RECIST 1.1 and was assessed by ICR. Only patients whose CR/PR response was confirmed by a second scan at least 4 weeks after the initial response, with no evidence of progression between the initial and CR/PR confirmation visit were included. CR: Disappearance of all target lesions (TLs) and non-TLs (NTLS) since baseline; any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of TL, referencing the baseline sum of diameters. Data obtained up until progression, or last evaluable assessment in the absence of progression were included in the assessment of ORR.
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
\[F 18\] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.
SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients
Area under plasma concentration-time curve from zero to infinity
Maximum plasma drug concentration
Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)
Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100
| Arm | Type | Description |
|---|---|---|
| Cediranib 30mg | EXPERIMENTAL | Cediranib 30mg |
| Cediranib 20mg + lomustine | OTHER | Cediranib 20mg + lomustine |
| Lomustine and Placebo Cediranib | ACTIVE_COMPARATOR | Lomustine and Placebo Cediranib |
| FOLFOX + placebo Cediranib | PLACEBO_COMPARATOR | FOLFOX + placebo Cediranib |
| Xelox + placebo Cediranib | PLACEBO_COMPARATOR | Xelox + placebo Cediranib |
| FOLFOX + Cediranib | EXPERIMENTAL | FOLFOX + Cediranib |
| XELOX + Cediranib | EXPERIMENTAL | XELOX + Cediranib |
| Cediranib | EXPERIMENTAL | Cediranib 20mg/day with weekly paclitaxel 70mg/m2/week. At the point of developing progressive disease (PD), patients will have the option of ceasing paclitaxel and continuing cediranib 20mg/day with olaparib 300mg bd continuously until further PD occurs. |
| combination of cediranib and olaparib | EXPERIMENTAL | Open label |
| 2 | ACTIVE_COMPARATOR | Fulvestrant Monotherapy |
| 3 | EXPERIMENTAL | AZD2171 + Fulvestrant |
| 1 | PLACEBO_COMPARATOR | Cediranib placebo |
| Cediranib 45 mg Fed | EXPERIMENTAL | Part A: Cediranib 45 mg Fed State |
| Cediranib 45 mg Fasted | EXPERIMENTAL | Part A: Cediranib 45 mg Fasted State |
| Cediranib 45 mg Fixed Dose | EXPERIMENTAL | Part B: Cediranib 45 mg Fixed Dose |
| Cediranib 30 - 90 mg Dose Escalation | EXPERIMENTAL | Part B: Cediranib 30 - 90 mg Dose Escalation |
| Treatment A | OTHER | Cediranib 20mg + Cisplatin + S-1 |
| Treatment B | OTHER | Cediranib 20mg + Cisplatin + Capecitabine |
| FOLFOX + Cediranib 20 mg | ACTIVE_COMPARATOR | FOLFOX + Cediranib 20 mg |
| FOLFOX + Cediranib 30 mg | ACTIVE_COMPARATOR | FOLFOX + Cediranib 30 mg |
| Name | Type | Description |
|---|---|---|
| Cediranib | DRUG | 30 mg/day, oral, until progression |
| Lomustine Chemotherapy | DRUG | 110 mg/m2 / Q6W, oral, until progression |
| Placebo Cediranib | DRUG | Oral, until progression |
| FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) | DRUG | intravenous infusion |
| XELOX (Capecitabine and Oxaliplatin) | DRUG | intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15) |
| Cediranib Placebo | DRUG | oral tablet |
| cediranib and olaparib | DRUG | Cediranib tablets oral dose 30 mg once daily; Olaparib(Lynparza) tablet 200 mg twice daily Dose reduction for both products is allowed |
| AZD2171 | DRUG | Oral tablet |
| Fulvestrant | DRUG | intramuscular injection |
| Bevacizumab | DRUG | intravenous infusion |
| 5-fluorouracil ( in FOLFOX) | DRUG | intravenous infusion |
| Leucovorin (in FOLFOX) | DRUG | intravenous infusion |
| Oxaliplatin (in FOLFOX) | DRUG | intravenous infusion |
| Cediranib 30 - 90 mg | DRUG | oral tablet dose escalation |
| 5-fluorouracil | DRUG | intravenous infusion |
| Leucovorin | DRUG | intravenous infusion |
| Oxaliplatin | DRUG | intravenous infusion |
| cediranib (RECENTIN TM, AZD2171) | DRUG | 20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8 |
| Cisplatin | DRUG | Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given. |
| S-1 | DRUG | Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. |
| Capecitabine | DRUG | Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion. |
| Etoposide | DRUG | Intravenous |
| Lomustine | DRUG | oral capsule |
| AZD0530 | DRUG | oral tablet multiple ascending doses 125 mg or 175 mg |
| FOLFOX | DRUG | intravenous infusion |
| Pemetrexed | DRUG | intravenous infusion |
| Irinotecan (administered with & without Cetuximab) | DRUG | intravenous injection |
| Docetaxel | DRUG | intravenous infusion |
| ZD1839 | DRUG | - |
Inclusion Criteria: * Confirmation of recurrent glioblastoma * Life expectancy ≥ 12 weeks * Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide Exclusion Criteria: * Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation...
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AZD2171 is an investigational small molecule being studied in oncology for the treatment of tumors, advanced cancer, advanced solid tumors, advanced breast cancer, advanced prostate adenocarcinoma, and carcinoma. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 2 clinical development.
AZD2171 is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information. The drug is being investigated for its biological activity in gastrointestinal stromal tumors and other solid tumors.
AZD2171 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical development for various oncology indications.
AZD2171 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed several clinical trials, including Phase 1 and Phase 2 studies, but remains under investigation.
AZD2171 has been studied in several completed clinical trials, including NCT00385203 for gastrointestinal stromal tumors, NCT00501605 for advanced solid tumors with liver metastases, NCT00502567 for solid tumors with chemotherapy, and NCT00503477 for solid tumors in Japan. These trials have been completed.
AZD2171 is also known as cediranib. In clinical trials, it has been referred to as cediranib (AZD2171), such as in the study of its biological activity in gastrointestinal stromal tumors. The drug is being developed by AstraZeneca.