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PARP Inhibitor

Pembrolizumab + Olaparib for Bile Duct Cancer

Phase 2
Waitlist Available
Led By Aiwu R He
Research Sponsored by Georgetown University
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 1 year
Awards & highlights

Study Summary

This trial will test a new combination of drugs to treat cholangiocarcinoma, a type of cancer that affects the bile ducts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
efficacy in terms of response rate
Secondary outcome measures
Safety and tolerability
efficacy in terms of duration of response
efficacy in terms of overall survival
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment2 Interventions
Pembrolizumab Q3W, IV infusion (day 1 of each 3 week cycle) Olaparib bid, Oral tablet continuously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,489 Total Patients Enrolled
Aiwu R HePrincipal InvestigatorGeorgetown University
1 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04306367 — Phase 2
Bile Duct Cancer Research Study Groups: Experimental
Bile Duct Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04306367 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04306367 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025