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cediranib and olaparib

Phase 2

Recurrent Platinum Resistant Ovarian Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 8, 2022

Target and mechanism

Molecular targetFLT1, FLT4, KDR, PDGFRB, PDGFRA, KIT
Target classInhibitor
ModalitySmall molecule

Also known as cediranib, Cediranib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

cediranib and olaparib · 1 trial · 1 indication

Phase 2 1
NCT02889900Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian CancerRecurrent Platinum Resistant Ovarian Cancer
COMPLETED62 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer
Recurrent Platinum Resistant Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Objective Response Rate (ORR) by Independent Central Review (ICR) Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.

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.

Secondary Endpoints

ORR by Investigator Assessment Using RECIST 1.1
From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
Median Duration of Response (DoR) by ICR and Investigator Assessment Using RECIST 1.1
From baseline to primary analysis DCO (8 months after last patient received their first dose of IPs). RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
Disease Control Rate (DCR) by ICR and Investigator Assessment Using RECIST 1.1
From baseline up to 6 months after first doses of IPs. RECIST assessments were performed at baseline and every 8 weeks (+/- 1 week) after first doses of IPs until disease progression.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
combination of cediranib and olaparibEXPERIMENTALOpen label

Interventions

NameTypeDescription
cediranib and olaparibDRUGCediranib tablets oral dose 30 mg once daily; Olaparib(Lynparza) tablet 200 mg twice daily Dose reduction for both products is allowed
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Eligibility Criteria

Age Range18 Years to 120 Years
SexFEMALE
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: 1. Ability and willingness to provide written informed consent, and to comply with the requirements of the protocol 2. Females aged ≥18 years with previous histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube o...

Countries:United States
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Frequently asked questions about cediranib and olaparib

What is Cediranib used for?

Cediranib is an investigational small molecule being studied in oncology. It has been evaluated in advanced solid tumors, recurrent platinum resistant ovarian cancer, metastatic colorectal cancer, advanced solid malignancies, and recurrent glioblastoma. Clinical trials have also explored its use in bowel obstruction and ovarian, fallopian tube, and primary peritoneal cancers.

What does Cediranib target?

Cediranib is a kinase inhibitor, belonging to the -nib class of drugs. It works by inhibiting kinase enzymes involved in tumor growth and blood vessel formation. This mechanism is being studied across multiple solid tumor types, including ovarian cancer and colorectal cancer.

Who makes Cediranib?

Cediranib is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of Cediranib across various cancer indications.

What phase is Cediranib in?

Cediranib is in Phase 2 clinical development. It has completed Phase 1 and Phase 3 trials, but it remains investigational and has not been approved by regulatory authorities. The drug is still being studied for safety and efficacy in cancer patients.

What clinical trials is Cediranib in?

Cediranib has been studied in several clinical trials. NCT00399035 was a Phase 3 trial in metastatic colorectal cancer with 1254 participants. NCT00750425 and NCT00981721 were Phase 1 pharmacokinetic studies in advanced solid tumors. NCT07648745 was a Phase 2 trial in platinum-resistant ovarian cancer.

Is Cediranib the same as RECENTIN?

Yes, Cediranib is also known as RECENTIN and AZD2171. The Phase 3 colorectal cancer trial NCT00399035 referred to Cediranib as AZD2171 and RECENTIN. These names refer to the same investigational drug developed by AstraZeneca.