What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as angiogenesis inhibitors like Cediranib Maleate and PARP inhibitors like Olaparib, have distinct side effect profiles. Cediranib Maleate, an angiogenesis inhibitor, can cause hypertension, diarrhea, and hepatotoxicity. Olaparib, a PARP inhibitor, is associated with nausea, fatigue, vomiting, and anemia. Both treatments aim to inhibit cancer cell growth but come with these potential adverse effects that patients should discuss with their healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer that are similar to Cediranib Maleate and Olaparib. Bevacizumab, an angiogenesis inhibitor, has been approved for use in combination with chemotherapy for advanced ovarian cancer. Olaparib, a PARP inhibitor, has been approved for maintenance treatment in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. Other PARP inhibitors like Niraparib and Rucaparib have also received FDA approval for similar indications, providing options for maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer.

What other types of research exist?

Promising novel alternatives to Cediranib Maleate and Olaparib for ovarian cancer patients include Bevacizumab, a VEGF inhibitor, which has shown improvement in progression-free survival (PFS) and overall survival (OS) in high-risk patients. Pazopanib, a tyrosine kinase inhibitor, has also demonstrated significant improvement in PFS as a maintenance treatment. Additionally, PARP inhibitors like Niraparib and Rucaparib are being evaluated and have shown activity in patients with BRCA mutations and other homologous recombination repair (HRR) gene abnormalities.

← Back to Search

Angiogenesis Inhibitor

Cediranib + Olaparib for Ovarian and Breast Cancer

Phase 1 & 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

Age >= 18 years

Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen

Must not have

Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or MRI scans should not be included on this study

Known human immunodeficiency virus (HIV)-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up adverse events monitored for 3 years, mortality assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs, cediranib maleate and olaparib, to treat patients with certain types of recurrent cancer. Cediranib maleate cuts off the blood supply to cancer cells, while olaparib stops them from repairing their DNA. The trial aims to find the best dose and see if the combination works better than using olaparib by itself. Combining cediranib, which cuts off the blood supply to cancer cells, with olaparib, which stops cancer cells from repairing their DNA, may help patients live longer without their cancer getting worse.

Who is the study for?

This trial is for adults with recurrent ovarian, fallopian tube, peritoneal cancer or triple-negative breast cancer. Participants must have had platinum-based chemotherapy (for ovarian cancer), be able to monitor their blood pressure daily, and not have used certain other treatments before. They should be in good health otherwise, with a life expectancy over 6 months and no severe uncontrolled conditions.

What is being tested?

The study is testing the effectiveness of combining Cediranib Maleate and Olaparib versus using Olaparib alone in treating specific recurrent cancers. It aims to find the best dose with manageable side effects and see if this combination can better prevent cancer growth by targeting both abnormal cell proliferation and the tumor's blood supply.

What are the potential side effects?

Potential side effects include high blood pressure from Cediranib Maleate affecting blood vessels; gastrointestinal issues due to absorption requirements; fatigue; possible organ inflammation; risk of developing myelodysplastic syndrome or acute myelogenous leukemia; allergic reactions similar to those caused by related compounds.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My breast cancer returned after treatments with Adriamycin and taxane.

Select...

Side effects from my previous cancer treatment are mild or gone, except for hair loss.

Select...

I agree to use birth control during and 3 months after the study.

Select...

My ovarian cancer treatment included platinum-based chemotherapy.

Select...

My kidney function is within the normal range.

Select...

My cancer is measurable or my CA125 levels are high.

Select...

I am fully active or able to carry out light work.

Select...

I can take pills and don't have stomach issues that affect medication absorption.

Select...

I have been diagnosed with a specific type of ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.

Exclusion Criteria

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

Select...

I do not have untreated brain metastases or symptoms from brain or spinal cord tumors.

Select...

I do not have HIV due to potential drug interactions.

Select...

My tests do not show signs of MDS or AML.

Select...

I am not pregnant, as the treatment could harm my unborn baby.

Select...

I am not taking strong medication that affects liver enzyme CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adverse events monitored for 3 years, mortality assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adverse events monitored for 3 years, mortality assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events monitored for 3 years, mortality assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I)

Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II)

The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).

+1 more

Secondary study objectives

Number of Participants With Treatment-related Toxicities of the Combination of Cediranib Maleate and Olaparib (Phase I)

Number of Participants With Treatment-related Toxicities of the Combination of Cediranib and Olaparib (Tablet Formulation) in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).

Overall Survival (Phase II)

+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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (cediranib maleate and olaparib)Experimental Treatment8 Interventions

Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.

Group II: Arm II (olaparib)Active Control7 Interventions

Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Multigated Acquisition Scan

2015

Completed Phase 3

~270

Cediranib Maleate

2010

Completed Phase 2

~660

Olaparib

2007

Completed Phase 4

~2190

0 / 15Eligibility 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 angiogenesis inhibitors and PARP inhibitors. Angiogenesis inhibitors, like Cediranib Maleate, work by blocking the blood supply that tumors need to grow, effectively starving the cancer cells. PARP inhibitors, such as Olaparib, prevent cancer cells from repairing their DNA, leading to cell death, particularly in cells with BRCA mutations. These mechanisms are crucial for ovarian cancer patients as they target the cancer cells' ability to grow and repair, potentially improving treatment outcomes and survival rates.