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Alkylating agent

ribociclib for Ovarian Cancer

Phase 1
Waitlist Available
Led By Lan G Coffman, M.D.
Research Sponsored by Ronald Buckanovich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing if a combination of two drugs can better treat ovarian cancer and slow tumor growth.

Eligible Conditions
  • Ovarian Cancer
  • Peritoneal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal tolerated dose (MTD) of ribociclib (LEE-011) when given with carboplatin + paclitaxel in platinum-sensitive recurrent ovarian cancer
Secondary outcome measures
Number of participants encountering toxicity at each dose level
Number of participants that respond to treatment
Overall Survival (OS)
+1 more

Side effects data

From 2020 Phase 3 trial • 502 Patients • NCT03096847
46%
NEUTROPENIA
43%
NAUSEA
38%
FATIGUE
33%
ALOPECIA
25%
NASOPHARYNGITIS
20%
LEUKOPENIA
20%
DIARRHOEA
20%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
ARTHRALGIA
19%
ALANINE AMINOTRANSFERASE INCREASED
18%
CONSTIPATION
18%
ANAEMIA
17%
HEADACHE
17%
VOMITING
15%
NEUTROPHIL COUNT DECREASED
15%
STOMATITIS
14%
INSOMNIA
13%
PAIN IN EXTREMITY
13%
BACK PAIN
13%
DYSPNOEA
12%
HOT FLUSH
11%
RASH
11%
THROMBOCYTOPENIA
11%
OEDEMA PERIPHERAL
11%
DECREASED APPETITE
10%
URINARY TRACT INFECTION
10%
WHITE BLOOD CELL COUNT DECREASED
10%
COUGH
10%
PRURITUS
8%
ELECTROCARDIOGRAM QT PROLONGED
8%
DYSPEPSIA
8%
VERTIGO
8%
MUSCULOSKELETAL PAIN
8%
DRY SKIN
8%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
6%
LACRIMATION INCREASED
6%
ABDOMINAL PAIN UPPER
6%
WEIGHT DECREASED
6%
ABDOMINAL PAIN
6%
PYREXIA
6%
BLOOD CREATININE INCREASED
6%
BONE PAIN
6%
DRY MOUTH
6%
ERYTHEMA
5%
DRY EYE
5%
DIZZINESS
4%
HYPERTENSION
4%
MYALGIA
4%
CYSTITIS
4%
DYSGEUSIA
4%
DEPRESSION
4%
SLEEP DISORDER
3%
GENERAL PHYSICAL HEALTH DETERIORATION
3%
BRONCHITIS
3%
MUSCULOSKELETAL CHEST PAIN
3%
POLYNEUROPATHY
2%
SEASONAL ALLERGY
2%
PLEURAL EFFUSION
2%
HYPOCALCAEMIA
1%
INFLUENZA
1%
METASTASES TO SPINE
1%
SKIN ULCER
1%
GASTROINTESTINAL INFECTION
1%
URETEROLITHIASIS
1%
DEVICE RELATED INFECTION
1%
ARTHROPOD BITE
1%
OROPHARYNGEAL PAIN
1%
CHEST PAIN
1%
CYSTITIS ESCHERICHIA
1%
SEPSIS
1%
INCISIONAL HERNIA
1%
COLON CANCER
1%
METASTASES TO BONE
1%
PULMONARY EMBOLISM
1%
ATRIAL FIBRILLATION
1%
ANAL HAEMORRHAGE
1%
HELICOBACTER GASTRITIS
1%
TUMOUR LYSIS SYNDROME
1%
TUMOUR PAIN
1%
WEIGHT INCREASED
1%
PANIC ATTACK
1%
FLANK PAIN
1%
SPINAL PAIN
1%
FEBRILE NEUTROPENIA
1%
CARDIAC FAILURE
1%
ILEUS
1%
INTESTINAL STRANGULATION
1%
COMPLICATION OF DEVICE INSERTION
1%
IMPAIRED HEALING
1%
PAIN
1%
HEPATIC CIRRHOSIS
1%
ABSCESS JAW
1%
APPENDICITIS
1%
MASTITIS
1%
PNEUMONIA
1%
HIP FRACTURE
1%
JAW FRACTURE
1%
RADIUS FRACTURE
1%
BLOOD BILIRUBIN INCREASED
1%
HYPERCALCAEMIA
1%
HYPERKALAEMIA
1%
DEVICE LOOSENING
1%
RENAL FAILURE
1%
RENAL IMPAIRMENT
1%
CIRCULATORY COLLAPSE
1%
TOOTHACHE
1%
BLOOD LACTATE DEHYDROGENASE INCREASED
1%
HYPOAESTHESIA
1%
HYPERFIBRINOLYSIS
1%
DRUG-INDUCED LIVER INJURY
1%
ABDOMINAL PAIN LOWER
1%
DEHYDRATION
1%
OSTEITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ribociclib + Letrozole Cohort B2
Ribociclib + Letrozole Cohort A
Ribociclib + Letrozole Cohort B1
Total
Ribociclib + Letrozole Cohort B

Trial Design

1Treatment groups
Experimental Treatment
Group I: RibociclibExperimental Treatment3 Interventions
Ribociclib (LEE-011) will be used as concurrent therapy with platinum-based chemotherapy in platinum-sensitive recurrent ovarian cancer. Participants will receive 200, 400, or 600mg of ribociclib per day in combination with carboplatin + paclitaxel. Subjects will receive 6 cycles of carboplatin + paclitaxel given weekly with ribociclib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Ronald BuckanovichLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Lan G Coffman, M.D.Principal InvestigatorUniversity of Pittsburgh Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer
Ronald Buckanovich 2017. "Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03056833.
~4 spots leftby Apr 2025
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