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PARP Inhibitor

Rucaparib for Solid Tumors (LODESTAR Trial)

Phase 2
Waitlist Available
Led By Kim Reiss-Binder, MD
Research Sponsored by pharmaand GmbH
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 from first dose of study drug until disease progression (up to approximately 2 years)
Awards & highlights

LODESTAR Trial Summary

This trial is testing a drug called rucaparib on patients with different types of cancer who have a specific genetic mutation.

Eligible Conditions
  • Solid Tumors

LODESTAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until disease progression (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until disease progression (up to approximately 2 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
Best Overall Response Rate by Investigator
Secondary outcome measures
Disease Control Rate
Duration of Response
Number of Participants Experiencing Treatment-emergent Adverse Events
+4 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213
76%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Pruritus
15%
Rash
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Anxiety
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

LODESTAR Trial Design

1Treatment groups
Experimental Treatment
Group I: RucaparibExperimental Treatment1 Intervention
Eligible participants will be enrolled in either Cohort A or Cohort B. Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

pharmaand GmbHLead Sponsor
21 Previous Clinical Trials
4,092 Total Patients Enrolled
Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
11,588 Total Patients Enrolled
Kim Reiss-Binder, MDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
4 Total Patients Enrolled

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
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
2020. "A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171700.
~16 spots leftby Apr 2025
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