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Antimetabolites

Olaparib for Colorectal Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

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 up to approximately 30 months

Awards & highlights

Study Summary

This trial is testing olaparib, with or without bevacizumab, compared to bevacizumab with a fluoropyrimidine, as a treatment for people with metastatic colorectal cancer who have not progressed following first-line induction.

Eligible Conditions

Metastatic Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 30 months 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) Using Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR).

Secondary outcome measures

Number of Participants Discontinuing Study Intervention Due to an AE

Number of Participants With One or More Adverse Events (AE)

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

+1 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

Nausea

47%

Fatigue

38%

Diarrhoea

29%

Abdominal pain

29%

Anaemia

28%

Constipation

27%

Decreased appetite

27%

Back pain

26%

Vomiting

21%

Arthralgia

19%

Pyrexia

18%

Asthenia

13%

Rash

13%

Nasopharyngitis

11%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Hyperglycaemia

Aspartate aminotransferase increased

Dizziness

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Olaparib + bevacizumabExperimental Treatment2 Interventions

Participants will receive olaparib (300 mg twice daily [BID] oral) + Bevacizumab (5 mg/kg intravenous [IV] once every 2 weeks [Q2W]) until progressive disease or end of study.

Group II: OlaparibExperimental Treatment1 Intervention

Participants will receive olaparib (300 mg BID) oral, until progressive disease or end of study.

Group III: Bevacizumab + chemotherapyActive Control4 Interventions

Participants will receive investigator's choice of either bevacizumab (7.5 mg/kg IV once every three weeks (Q3W)) + capecitabine (1000 mg/m^2 BID for 14 days, then 7 days off, Q3W) or bevacizumab (5 mg/kg IV Q2W) + 5-FU (2400 mg/m2 IV over 46 to 48 hours Q2W; bolus 5-FU (400 mg/m2) can be added prior to infusional 5-FU, per local standards and at the investigator's discretion). Leucovorin or levoleucovorin 400 mg/m^2 (leucovorin) or 200 mg/m^2 (levoleucovorin) Q2W IV infusion may be added per investigator's discretion. Treatment will continue until progressive disease or end of study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2140

Bevacizumab

2013

Completed Phase 4

~5280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,493 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,218 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,151 Total Patients Enrolled

Media Library

5-FU (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04456699 — Phase 3

Colorectal Cancer Research Study Groups: Bevacizumab + chemotherapy, Olaparib, Olaparib + bevacizumab

Colorectal Cancer Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT04456699 — Phase 3

5-FU (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04456699 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research opportunity still enrolling new participants?

"The clinicaltrial.gov website indicates that this particular trial is not recruiting patients at this time. This study was initially posted on August 19th, 2020 but was last updated on September 19th, 2022. There are 2070 other trials that are actively recruiting patients."

Answered by AI

Could you list any other times Olaparib has been used in a clinical setting?

"1162 total clinical trials are researching Olaparib with 330 of them being in the critical third phase. The majority of these trials are based in Guangzhou, Guangdong, but there are 51410 locations running these studies."

Answered by AI

What is Olaparib typically used to treat?

"Olaparib is often used to treat rectal carcinoma. This medication is also effective for other conditions, such as locally advanced nonsquamous non-small cell lung cancer, metastatic colorectal cancer, and advanced gastric cancer."

Answered by AI

Has Olaparib's efficacy been cleared by the FDA?

"This drug has undergone multiple rounds of testing and has been shown to be effective and safe, so we have given it a score of 3."

Answered by AI

What are we aiming to learn from this research?

"The primary objective of this trial is to measure progression-free survival (PFS) using RECIST 1.1 as assessed by blinded independent central review (BICR). Secondary objectives include duration of response (DOR), overall survival (OS), and number of participants with one or more adverse events (AEs)."

Answered by AI

Are there different locations where this research project is taking place?

"Currently, this trial is being conducted at 25 sites which are situated in various locations, including Roanoke, Billings, and Temple. If you choose to enroll in the trial, it is advised that you select a site nearest to your location to limit travel."

Answered by AI