Rucaparib for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
LeiomyosarcomaRucaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether combining two drugs, rucaparib and nivolumab, may be effective in treating leiomyosarcoma (LMS), a type of cancer.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: at 24 weeks

at 24 weeks
Progression free survival (PFS)
by 24 weeks
Best objective response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Rucaparib 40 mg QD (Part 1)
50%Decreased appetite
50%Nausea
33%Dehydration
33%Diarrhoea
33%Headache
33%Vomiting
17%Hyponatraemia
17%Pharyngitis
17%Vulvovaginal pain
17%Dizziness
17%Abdominal distension
17%Abdominal pain
17%Rhinorrhoea
17%Vaginal fistula
17%Ascites
17%Hypokalaemia
17%Hepatomegaly
17%Skin infection
17%Heart rate increased
17%Splenomegaly
17%Joint stiffness
17%Hyperglycaemia
17%Hypoalbuminaemia
17%Musculoskeletal chest pain
17%Nodule
17%Paraesthesia
17%Abdominal pain upper
17%Musculoskeletal discomfort
17%Hypercholesterolaemia
17%Hydronephrosis
17%Atrial fibrillation
17%Small intestinal obstruction
17%Asthenia
17%Weight decreased
17%Musculoskeletal stiffness
17%Fatigue
17%Arthralgia
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT01482715) in the Rucaparib 40 mg QD (Part 1) ARM group. Side effects include: Decreased appetite with 50%, Nausea with 50%, Dehydration with 33%, Diarrhoea with 33%, Headache with 33%.

Trial Design

1 Treatment Group

Rucaparib in combination with Nivolumab
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Rucaparib · No Placebo Group · Phase 2

Rucaparib in combination with NivolumabExperimental Group · 2 Interventions: Rucaparib, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 24 weeks

Who is running the clinical trial?

Clovis Oncology, Inc.Industry Sponsor
62 Previous Clinical Trials
10,310 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,518 Total Patients Enrolled
7 Trials studying Leiomyosarcoma
263 Patients Enrolled for Leiomyosarcoma
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,214 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
35 Patients Enrolled for Leiomyosarcoma
Sujana Movva, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must have a histologically confirmed unresectable/metastatic LMS.
Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy (e.g
You are 18 years or older.
You are willing and able to provide written informed consent/assent for the trial.
A paraffin block or at least 20 unstained slides are acceptable.
Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
The absolute neutrophil count (ANC) is greater than 1.5 K/mcL.