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Ribociclib for Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute, Salt Lake City, UTMetastatic Breast Cancer+1 MoreRibociclib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to assess the maximum tolerated dose of two drugs, ribociclib and belinostat, in combination. The trial will start with a dose escalation, followed by an expansion cohort at the identified dose. Dose escalation will be open to patients with triple-negative breast cancer or ovarian cancer. Dose expansion will only be open to patients with triple-negative breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer
  • Recurrent Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
RLY-2608
1
Afuresertib
1
DAN-222

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 36 months

36 months
Objective Response Rate (ORR)
Progression Free Survival (PFS)
frequency and characterization of AEs and SAEs
Day 28
MTD of ribociclib and belinostat combination

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
RLY-2608
1
Afuresertib
1
DAN-222

Side Effects for

Ribociclib + Fulvestrant
55%Neutropenia
45%Nausea
31%Fatigue
29%Diarrhoea
26%Vomiting
24%Constipation
24%Arthralgia
22%Headache
22%Cough
20%Pruritus
19%Alopecia
18%Neutrophil count decreased
18%Rash
17%Back pain
16%Anaemia
16%Leukopenia
16%Decreased appetite
14%Asthenia
14%Alanine aminotransferase increased
14%Dyspnoea
13%Aspartate aminotransferase increased
13%Pain in extremity
13%Hot flush
12%Oedema peripheral
12%White blood cell count decreased
12%Dizziness
12%Insomnia
11%Nasopharyngitis
10%Dyspepsia
10%Abdominal pain upper
10%Stomatitis
10%Pyrexia
10%Urinary tract infection
10%Hypertension
9%Upper respiratory tract infection
8%Bone pain
8%Musculoskeletal pain
8%Myalgia
8%Dry skin
7%Abdominal pain
7%Blood creatinine increased
7%Gamma-glutamyltransferase increased
7%Muscle spasms
7%Dysgeusia
6%Electrocardiogram QT prolonged
6%Neck pain
6%Anxiety
6%Depression
6%Oropharyngeal pain
5%Dry mouth
5%Thrombocytopenia
5%Influenza like illness
3%Musculoskeletal chest pain
2%Pneumonia
1%Acute kidney injury
1%Non-cardiac chest pain
1%Hip fracture
1%Dehydration
1%Febrile neutropenia
1%Pleural effusion
1%Pneumothorax
1%Pulmonary embolism
This histogram enumerates side effects from a completed 2023 Phase 3 trial (NCT02422615) in the Ribociclib + Fulvestrant ARM group. Side effects include: Neutropenia with 55%, Nausea with 45%, Fatigue with 31%, Diarrhoea with 29%, Vomiting with 26%.

Trial Design

1 Treatment Group

Treatment: all patients
1 of 1

Experimental Treatment

34 Total Participants · 1 Treatment Group

Primary Treatment: Ribociclib · No Placebo Group · Phase 1

Treatment: all patientsExperimental Group · 2 Interventions: Ribociclib, Belinostat · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Belinostat
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Acrotech BiopharmaUNKNOWN
University of UtahLead Sponsor
1,008 Previous Clinical Trials
1,787,348 Total Patients Enrolled
NovartisIndustry Sponsor
1,587 Previous Clinical Trials
2,703,755 Total Patients Enrolled
15 Trials studying Metastatic Breast Cancer
8,741 Patients Enrolled for Metastatic Breast Cancer
Theresa Werner, MDPrincipal InvestigatorHuntsman Cancer Institute
2 Previous Clinical Trials
31 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Has there previously been research conducted on Ribociclib?

"Ribociclib was first studied at Azienda Ospedaliera Universitaria Federico II in 2012 and there are currently 58 concluded trials. Of the 55 active studies, many of them take place near Fairfax, Virginia." - Anonymous Online Contributor

Unverified Answer

In what medical circumstances is Ribociclib typically prescribed?

"Ribociclib is chiefly given to those with refractory peripheral t-cell lymphoma unspecified. It has also proven effective for malignant neoplasms, postmenopause, and relapsed peripheral t-cell lymphoma cases." - Anonymous Online Contributor

Unverified Answer

How many participants are expected to be recruited for this trial?

"Affirmative, the clinicaltrials.gov records demonstrate that this research is recruiting volunteers at present. The trial was originally posted on May 3rd 2021 and has been updated most recently on May 3rd 2022. 34 subjects are required from 2 sites in total." - Anonymous Online Contributor

Unverified Answer

Has the Federal Drug Administration certified Ribociclib for therapeutic applications?

"As a phase 1 trial, there is limited data available on the safety and efficacy of ribociclib. Therefore, our team has assigned it a score of 1/3." - Anonymous Online Contributor

Unverified Answer

Is this trial the inaugural effort of its kind?

"As of now, 55 clinical trials related to Ribociclib are taking place in 447 cities and 48 nations. The first trial commenced eight years ago with the sponsorship of Pfizer and included 189 test subjects. With 58 studies already finished since then, ample data regarding this medication has been amassed." - Anonymous Online Contributor

Unverified Answer

Are participants currently being enrolled for this medical experiment?

"As per clinicaltrials.gov, this medical study is actively in search of volunteers and was initially established on May 3rd 2021 before being revisited on the same date a year later." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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