What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as PARP inhibitors (e.g., Olaparib) and VEGFR inhibitors (e.g., Cediranib Maleate), are associated with several side effects. Olaparib often causes nausea, fatigue, vomiting, and anemia. Cediranib Maleate, on the other hand, can lead to hypertension, diarrhea, and hepatotoxicity. Both treatments aim to inhibit tumor growth but come with these notable adverse reactions that patients should discuss with their healthcare providers.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of ovarian cancer, including Olaparib, Niraparib, and Rucaparib. These drugs are used primarily as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer, particularly those with BRCA mutations. Olaparib has shown efficacy in improving progression-free survival (PFS) in both BRCA-mutated and non-BRCA-mutated cases. Additionally, Bevacizumab, an angiogenesis inhibitor targeting VEGF, has been approved for use in combination with chemotherapy and as maintenance therapy for ovarian cancer, demonstrating significant improvements in PFS.

What other types of research exist?

Promising alternatives to Olaparib and Cediranib Maleate for ovarian cancer treatment include Niraparib, another PARP inhibitor, which has shown efficacy in clinical trials. Additionally, Bevacizumab, a VEGF inhibitor, has been evaluated in combination with standard chemotherapy and has shown potential benefits. Pazopanib, another VEGFR inhibitor, has also been studied for maintenance therapy in ovarian cancer. These alternatives offer different mechanisms of action and have demonstrated effectiveness in clinical settings.

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Tyrosine Kinase Inhibitor

Cediranib + Olaparib for Ovarian Cancer

Q: What is the mechanism of action of this treatment?

Ovarian cancer treatments often include PARP inhibitors like Olaparib and VEGFR inhibitors like Cediranib Maleate. PARP inhibitors work by blocking the PARP enzyme, which helps repair DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, leading to cell death. VEGFR inhibitors, on the other hand, target the vascular endothelial growth factor receptor, which is involved in the formation of blood vessels that supply the tumor. By inhibiting this pathway, Cediranib Maleate can reduce tumor growth and spread. These targeted therapies are crucial for ovarian cancer patients as they offer a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to conventional chemotherapy.

Phase 2

Waitlist Available

Led By Joyce F Liu

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) less than or equal to the upper limit of normal

For platinum sensitive cohort: Cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy, no limit on the number of platinum-based lines, and no more than one prior non-platinum based line of therapy in the recurrent setting

Must not have

Participants may not have had prior use of PARP inhibitors; patients may not have received prior treatment affecting the VEGF pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, or sorafenib

Participants with any of the following: History of myocardial infarction within six months, Unstable angina, New York Heart Association (NYHA) classification of III or IV, Prior treatment with anthracyclines, Prior treatment with trastuzumab, Prior central thoracic radiation therapy (RT), History of myocardial infarction within 6 to 12 months, A NYHA classification of II controlled with treatment, Prior history of impaired cardiac function, History of a stroke or transient ischemic attack within six months, Clinically significant peripheral vascular disease or vascular disease, Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib, Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease, History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib, Current use of a prohibited medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a drug called olaparib and a drug called cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).

Who is the study for?

This trial is for adults with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Participants must have measurable disease and not have used PARP inhibitors before. They should be in good physical condition (ECOG <=2) and able to take oral medications. Those with controlled blood pressure, no recent chemotherapy or invasive cancers (with some exceptions), and no history of certain heart conditions can join.

What is being tested?

The study tests the effectiveness of combining Cediranib Maleate and Olaparib in treating patients whose ovarian cancer has returned after treatment. It examines if these drugs can block enzymes needed for tumor growth, using imaging techniques like CT scans and MRIs to measure results.

What are the potential side effects?

Potential side effects may include nausea, fatigue, high blood pressure, bleeding risks, heart problems due to Cediranib Maleate; Olaparib might cause anemia, digestive issues, taste changes or fatigue. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thyroid function is normal, with no symptoms of dysfunction.

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My cancer did not worsen within 6 months after my last platinum-based treatment.

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function is within the normal range.

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I am willing to have biopsies before and during treatment.

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I am 18 years old or older.

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I have a tumor that can be measured with scans or exams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not used PARP inhibitors or drugs affecting the VEGF pathway for my cancer.

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Criterion: You have had a heart attack, unstable chest pain, or severe heart failure in the last six months. You have also had specific cancer treatments or surgeries within certain timeframes, or are currently dealing with certain medical conditions or medications.

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I have never had a hypertensive crisis or brain issues due to high blood pressure.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) in Platinum-Resistant Ovarian Cancer

Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer

Secondary study objectives

Biomarker Signature Development

Change in Circulating Endothelial Cells/Circulating Endothelial Precursor Cells

Genetic Alterations

+2 more

Other study objectives

Ecediranib-olaparib application web portal metrics

Incidence of ecediranib-olaparib application user support call

Perceived usability and satisfaction of ecediranib-olaparib application from health care professionals

+1 more

Side effects data

From 2016 Phase 2 trial • 53 Patients • NCT01132820

81%

Fatigue

69%

Diarrhea

60%

Hypertension

48%

Anorexia

46%

Nausea

35%

Anemia

33%

Weight Loss

31%

Vomiting

31%

Peripheral Sensory Neuropathy

29%

Mucositis Oral

29%

Hypothyroidism

27%

Constipation

25%

Aspartate Aminotransferase Increased

23%

Headache

23%

Abdominal Pain

23%

Platelet Count Decreased

23%

Creatinine Increased

23%

White Blood Cell Decreased

21%

Urinary Tract Infection

21%

Pain

21%

Hyponatremia

21%

Proteinuria

19%

Hypoalbuminemia

19%

Alanine Aminotransferase Increased

19%

Hypomagnesemia

19%

Hypokalemia

17%

Dry Mouth

17%

Hyperglycemia

15%

Dyspnea

15%

Alkaline Phosphatase Increased

15%

Hypocalcemia

13%

Myalgia

10%

Dehydration

10%

Dizziness

10%

Voice Alteration

10%

Oral Pain

Hoarseness

Palmar-Plantar Erythrodysesthesia Syndrome

Neoplasms Benign, Malignant And Unspecified (Incl

Arthralgia

Dyspepsia

Neutrophil Count Decreased

Back Pain

Anxiety

Dry Skin

Cough

Blurred Vision

Hypoglycemia

Generalized Muscle Weakness

Thromboembolic Event

Insomnia

Tinnitus

Fever

Bruising

Skin And Subcutaneous Tissue Disorders - Other

Rash Maculo-Papular

Fecal Incontinence

Alopecia

Dysgeusia

Abdominal Distension

Flatulence

Upper Respiratory Infection

Epistaxis

Bladder Infection

Dry Eye

Rectal Hemorrhage

Gastroesophageal Reflux Disease

Edema Limbs

Inr Increased

Activated Partial Thromboplastin Time Prolonged

Hypophosphatemia

Hypernatremia

Hyperkalemia

Pelvic Pain

Cognitive Disturbance

Gastric Hemorrhage

Lymphocyte Count Decreased

Pruritus

General Disorders And Administration Site Conditio

Middle Ear Inflammation

Hypotension

Blood Bilirubin Increased

Muscle Weakness Lower Limb

Hemoglobin Increased

Cholesterol High

Multi-Organ Failure

Blood And Lymphatic System Disorders - Other

Rectal Pain

Esophageal Pain

Gallbladder Pain

Nasal Congestion

Urinary Tract Obstruction

Ascites

Pain In Extremity

Reversible Posterior Leukoencephalopathy Syndrome

Vaginal Hemorrhage

Pleuritic Pain

Allergic Rhinitis

Acidosis

Chest Wall Pain

Acute Kidney Injury

Breast Pain

Edema Face

Gait Disturbance

Bullous Dermatitis

Oral Hemorrhage

Peripheral Motor Neuropathy

Colitis

Anal Hemorrhage

Oral Dysesthesia

Gastrointestinal Pain

Joint Range Of Motion Decreased

Hematuria

Vaginal Pain

Confusion

Death Nos

Myocardial Infarction

Colonic Perforation

Rectal Fistula

Ileal Obstruction

Peritoneal Necrosis

Lung Infection

Chest Pain - Cardiac

Sinus Tachycardia

Sinus Bradycardia

Vertigo

Conjunctivitis

Endocrine Disorders - Other

Eye Disorders - Other

Hyperthyroidism

Dysphagia

Gastric Ulcer

Flu Like Symptoms

Skin Infection

Investigations - Other

Chills

Lipase Increased

Syncope

Neck Pain

Flank Pain

Intracranial Hemorrhage

Memory Impairment

Vaginal Dryness

Depressed Level Of Consciousness

Depression

Skin Induration

Urinary Tract Pain

Respiratory Failure

Hot Flashes

Hematoma

100%

80%

60%

40%

20%

Study treatment Arm

Cediranib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib and cediranib maleate)Experimental Treatment9 Interventions

Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy of tumor, blood sample collection, MUGA or echocardiogram, and CT scan or MRI scan throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multigated Acquisition Scan

2015

Completed Phase 3

~270

Computed Tomography

2017

Completed Phase 2

~2740

Echocardiography

2013

Completed Phase 4

~11580

Biospecimen Collection

2004

Completed Phase 3

~2020

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biopsy

2014

Completed Phase 4

~1090

Cediranib Maleate

2010

Completed Phase 2

~660

Olaparib

2007

Completed Phase 4

~2190

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ovarian cancer treatments often include PARP inhibitors like Olaparib and VEGFR inhibitors like Cediranib Maleate. PARP inhibitors work by blocking the PARP enzyme, which helps repair DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, leading to cell death. VEGFR inhibitors, on the other hand, target the vascular endothelial growth factor receptor, which is involved in the formation of blood vessels that supply the tumor. By inhibiting this pathway, Cediranib Maleate can reduce tumor growth and spread. These targeted therapies are crucial for ovarian cancer patients as they offer a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to conventional chemotherapy.

The safety of antiangiogenic agents and PARP inhibitors in platinum-sensitive recurrent ovarian cancer.