Ribociclib for Carcinosarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinosarcoma+8 MoreRibociclib - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new cancer drug to see if it is safe and works well against cancer cells.

Eligible Conditions
  • Carcinosarcoma
  • Advanced Solid Tumors
  • Esophageal Cancer
  • Endometrial Cancer
  • HER2-negative Breast Cancer
  • Stomach Cancer
  • Estrogen Receptor Positive Breast Cancer
  • Ovarian Cancer
  • CCNE1 Amplification

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 26 Secondary · Reporting Duration: Up to 43 months

Approximately 21 months
[Phase 1] Accumulation ratio (R)
[Phase 1] Apparent oral clearance(CL/F)
[Phase 1] Apparent volume of distribution (Vz/F)
[Phase 1] Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24)
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-222
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-222
[Phase 1] Maximum plasma drug concentration (Cmax)
[Phase 1] Overall response rate (ORR)
[Phase 1] Rate and severity of adverse events
[Phase 1] Terminal elimination half-life (t½)
[Phase 1] Time of last quantifiable plasma drug concentration (Tlast)
[Phase 1] Time to maximum plasma drug concentration (Tmax)
[Phase 1] To assess treatment-induced modulation of cyclin E/CDK2 pathway biomarkers
[Phase 1] Trough concentration (Ctrough)
[Phase 2] Overall response rate (ORR)
[Phase 2] Rate and severity of adverse events
Approximately 43 months
[Phase 1 and Phase 2] Change in CA-125 levels
[Phase 1 and Phase 2] Clinical benefit rate (CBR)
[Phase 1 and Phase 2] Disease control rate (DCR)
[Phase 1 and Phase 2] Duration of Response (DOR)
[Phase 2] Overall survival (OS)
[Phase 2] Progression free survival (PFS)
Up to 43 months
[Phase 1 and Phase 2] Accumulation ratio (R)
[Phase 1 and Phase 2] Apparent oral clearance(CL/F)
[Phase 1 and Phase 2] Apparent volume of distribution (Vz/F)
[Phase 1 and Phase 2] Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24)
[Phase 1 and Phase 2] Maximum plasma drug concentration (Cmax)
[Phase 1 and Phase 2] Terminal elimination half-life (t½)
[Phase 1 and Phase 2] Time of last quantifiable plasma drug concentration (Tlast)
[Phase 1 and Phase 2] Time to maximum plasma drug concentration (Tmax)
[Phase 1 and Phase 2] Trough concentration (Ctrough)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Ribociclib + Letrozole + Goserelin/Leuprolide
61%Neutropenia
36%Nausea
23%Fatigue
21%Arthralgia
21%Diarrhoea
20%Alopecia
20%Vomiting
19%Asthenia
19%Neutrophil count decreased
18%Anaemia
18%Leukopenia
17%Constipation
16%Alanine aminotransferase increased
15%Cough
15%Hot flush
14%Aspartate aminotransferase increased
14%Headache
13%Back pain
13%Pruritus
12%Decreased appetite
12%Pyrexia
12%Rash
10%White blood cell count decreased
9%Oedema peripheral
9%Stomatitis
8%Pain in extremity
8%Insomnia
8%Thrombocytopenia
8%Dyspnoea
7%Bone pain
7%Electrocardiogram QT prolonged
7%Dry skin
7%Abdominal pain
7%Abdominal pain upper
7%Dyspepsia
7%Dizziness
7%Hypertension
6%Upper respiratory tract infection
6%Musculoskeletal pain
6%Urinary tract infection
6%Nasopharyngitis
6%Blood creatinine increased
6%Myalgia
5%Lymphopenia
1%Febrile neutropenia
1%Pneumonia
1%Pleural effusion
1%Pulmonary embolism
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02941926) in the Ribociclib + Letrozole + Goserelin/Leuprolide ARM group. Side effects include: Neutropenia with 61%, Nausea with 36%, Fatigue with 23%, Arthralgia with 21%, Diarrhoea with 21%.

Trial Design

4 Treatment Groups

BLU-222 Monotherapy
1 of 4
BLU-222 + fulvestrant
1 of 4
BLU-222 + Ribociclib + Fulvestrant
1 of 4
BLU-222 + Carboplatin
1 of 4

Experimental Treatment

366 Total Participants · 4 Treatment Groups

Primary Treatment: Ribociclib · No Placebo Group · Phase 1 & 2

BLU-222 MonotherapyExperimental Group · 2 Interventions: Fulvestrant, BLU-222 · Intervention Types: Drug, Drug
BLU-222 + fulvestrantExperimental Group · 2 Interventions: Fulvestrant, BLU-222 · Intervention Types: Drug, Drug
BLU-222 + Ribociclib + FulvestrantExperimental Group · 3 Interventions: Ribociclib, Fulvestrant, BLU-222 · Intervention Types: Drug, Drug, Drug
BLU-222 + CarboplatinExperimental Group · 2 Interventions: BLU-222, Carboplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~8170
Fulvestrant
2011
Completed Phase 3
~3810
Carboplatin
2014
Completed Phase 3
~7230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 43 months

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
27 Previous Clinical Trials
4,523 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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