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Niraparib for Bile Duct Cancer

Phase 2
Waitlist Available
Research Sponsored by Walid Shaib, MD
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 5years
Awards & highlights

Study Summary

This study is evaluating whether a new treatment for cholangiocarcinoma is effective.

Eligible Conditions
  • Bile Duct Cancer
  • Hereditary Hemorrhagic Telangiectasia (HHT)
  • Cancer

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Frequency and Severity of Adverse Events
+2 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Head injury
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Investigational GroupExperimental Treatment2 Interventions
Cycle 1-4 (cycle length 4 weeks): Niraparib 300 mg taken orally on days 1-21 and Dostarlimab 500 mg intravenously on day 1 Cycle 5 and above (cycle length 3 weeks): Niraparib 300 mg taken orally on days 1-21 and 1000 mg intravenously on day 1 of every other cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

Walid Shaib, MDLead Sponsor
1 Previous Clinical Trials
84 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,458 Total Patients Enrolled
Emory UniversityOTHER
1,638 Previous Clinical Trials
2,560,532 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
Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma
Walid Shaib, MD 2021. "Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895046.
~0 spots leftby Apr 2025
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