Cediranib Maleate for Ovarian Serous Papillary Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ovarian Serous Papillary Adenocarcinoma+10 MoreCediranib Maleate - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing the side effects and best dose of two drugs, cediranib and olaparib, compared to olaparib alone, in treating patients with recurrent ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.

Eligible Conditions
  • High Grade Ovarian Cancer
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Cancer
  • Ovarian Serous Papillary Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Breast Cancer
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Cancer
  • Recurrent Primary Peritoneal Carcinoma
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Adverse Events monitored for 3 years, mortality assessed up to 5 years

Year 5
Number of Participants With Treatment-related Toxicities of the Combination of Cediranib Maleate and Olaparib (Phase I)
At 28 Days
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I)
At 28 days
Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I)
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).
Year 5
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)
Up to 3 years
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).
Up to 5 years
Overall Survival (Phase II)
Tumor Response Rate (Objective Response Rate) Defined by Response Evaluation Criteria in Solid Tumors Criteria (Phase II)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Cediranib
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%Abdominal Pain
23%Platelet Count Decreased
23%Creatinine Increased
23%White Blood Cell Decreased
23%Headache
21%Pain
21%Urinary Tract Infection
21%Hyponatremia
21%Proteinuria
19%Hypokalemia
19%Alanine Aminotransferase Increased
19%Hypoalbuminemia
19%Hypomagnesemia
17%Dry Mouth
17%Hyperglycemia
15%Alkaline Phosphatase Increased
15%Hypocalcemia
15%Dyspnea
13%Myalgia
10%Oral Pain
10%Dehydration
10%Dizziness
10%Voice Alteration
8%Arthralgia
8%Neoplasms Benign, Malignant And Unspecified (Incl
8%Dyspepsia
8%Neutrophil Count Decreased
8%Back Pain
8%Anxiety
8%Hoarseness
8%Palmar-Plantar Erythrodysesthesia Syndrome
6%Insomnia
6%Tinnitus
6%Blurred Vision
6%Fever
6%Bruising
6%Hypoglycemia
6%Generalized Muscle Weakness
6%Cough
6%Dry Skin
6%Thromboembolic Event
4%Bladder Infection
4%Dry Eye
4%Rectal Hemorrhage
4%Abdominal Distension
4%Gastroesophageal Reflux Disease
4%Fecal Incontinence
4%Flatulence
4%Edema Limbs
4%Upper Respiratory Infection
4%Inr Increased
4%Activated Partial Thromboplastin Time Prolonged
4%Hypophosphatemia
4%Hypernatremia
4%Hyperkalemia
4%Dysgeusia
4%Pelvic Pain
4%Cognitive Disturbance
4%Rash Maculo-Papular
4%Epistaxis
4%Skin And Subcutaneous Tissue Disorders - Other
4%Alopecia
2%Hematuria
2%Vaginal Pain
2%Colitis
2%Anal Hemorrhage
2%Oral Dysesthesia
2%Gastrointestinal Pain
2%Joint Range Of Motion Decreased
2%Peripheral Motor Neuropathy
2%Ascites
2%Confusion
2%Death Nos
2%Myocardial Infarction
2%Colonic Perforation
2%Rectal Fistula
2%Ileal Obstruction
2%Multi-Organ Failure
2%Peritoneal Necrosis
2%Lung Infection
2%Urinary Tract Obstruction
2%Chest Pain - Cardiac
2%Blood And Lymphatic System Disorders - Other
2%Middle Ear Inflammation
2%Sinus Tachycardia
2%Sinus Bradycardia
2%Vertigo
2%Conjunctivitis
2%Endocrine Disorders - Other
2%Eye Disorders - Other
2%Hyperthyroidism
2%Dysphagia
2%Oral Hemorrhage
2%Gastric Hemorrhage
2%Esophageal Pain
2%Gastric Ulcer
2%Rectal Pain
2%General Disorders And Administration Site Conditio
2%Flu Like Symptoms
2%Gait Disturbance
2%Edema Face
2%Skin Infection
2%Investigations - Other
2%Gallbladder Pain
2%Hemoglobin Increased
2%Chills
2%Lymphocyte Count Decreased
2%Lipase Increased
2%Cholesterol High
2%Blood Bilirubin Increased
2%Syncope
2%Muscle Weakness Lower Limb
2%Acidosis
2%Pain In Extremity
2%Neck Pain
2%Chest Wall Pain
2%Flank Pain
2%Reversible Posterior Leukoencephalopathy Syndrome
2%Intracranial Hemorrhage
2%Memory Impairment
2%Vaginal Dryness
2%Depressed Level Of Consciousness
2%Depression
2%Skin Induration
2%Urinary Tract Pain
2%Acute Kidney Injury
2%Breast Pain
2%Nasal Congestion
2%Pruritus
2%Respiratory Failure
2%Vaginal Hemorrhage
2%Pleuritic Pain
2%Allergic Rhinitis
2%Bullous Dermatitis
2%Hypotension
2%Hot Flashes
2%Hematoma
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT01132820) in the Cediranib ARM group. Side effects include: Fatigue with 81%, Diarrhea with 69%, Hypertension with 60%, Anorexia with 48%, Nausea with 46%.

Trial Design

2 Treatment Groups

Arm II (olaparib)
1 of 2
Arm I (cediranib maleate and olaparib)
1 of 2

Active Control

Experimental Treatment

155 Total Participants · 2 Treatment Groups

Primary Treatment: Cediranib Maleate · No Placebo Group · Phase 1 & 2

Arm I (cediranib maleate and olaparib)Experimental Group · 2 Interventions: Cediranib Maleate, Olaparib · Intervention Types: Drug, Drug
Arm II (olaparib)
Drug
ActiveComparator Group · 1 Intervention: Olaparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
Not yet FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: adverse events monitored for 3 years, mortality assessed up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,083 Previous Clinical Trials
41,141,403 Total Patients Enrolled
Joyce F LiuPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
691 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Prior chemotherapy for ovarian cancer patients must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy.
Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen.
You have measurable disease by RECIST 1.1 criteria.
You have a high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer, and you have a known deleterious BRCA germline mutation by standard clinical testing (Myriad BRAC Analysis).