Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04456699) enrolled 335 people across three groups: 111 received a combination of olaparib and bevacizumab, 115 received olaparib alone, and 109 received bevacizumab combined with chemotherapy. The trial was primarily measuring how long participants went without their cancer growing or spreading — known as "progression-free survival" — as judged by an independent review team who did not know which treatment each person was receiving. The reported data shows that the median time before the cancer progressed (or death occurred) was 3.7 months in the olaparib-plus-bevacizumab group, 3.6 months in the olaparib-alone group, and 5.5 months in the bevacizumab-plus-chemotherapy group. For overall survival (how long participants lived from the start of the trial), the reported figures were 21.2 months, 21.6 months, and 19.9 months respectively. The proportion of participants whose tumours shrank meaningfully — called the "objective response rate" — was reported as 4.8% in the olaparib-plus-bevacizumab group, 1.9% in the olaparib group, and 4.8% in the bevacizumab-plus-chemotherapy group. The duration of that tumour response was not reported for any of the three groups. The reported data also shows that unintended medical events (called "adverse events") during the trial were recorded in 101 of 111 participants in the olaparib-plus-bevacizumab group, 91 of 113 in the olaparib group, and 96 of 108 in the bevacizumab-plus-chemotherapy group. A smaller number — 6, 4, and 7 participants in each group respectively — stopped their treatment early because of such an event. Noting that zero participants were recorded as having formally "completed" the study, the data does not explain the reasons for this, and no further detail was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Colorectal Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body or cannot be removed by surgery, confirmed by a tissue biopsy.
- Your cancer did not get worse (it stayed stable or improved) after receiving at least 6 rounds of a chemotherapy combination called FOLFOX plus bevacizumab, or at least 4 rounds of CAPOX plus bevacizumab, as your first treatment for advanced colorectal cancer.
- You had to stop taking the chemotherapy drug oxaliplatin because it caused serious side effects that your doctor felt were unacceptable — for example, severe or long-lasting nerve damage.
- You are enrolled in the trial within 2 to 6 weeks after your last dose of oxaliplatin-containing chemotherapy.
- You have provided the required scan images taken before or during your chemotherapy treatment, and you have had a new scan within 28 days before joining the trial.
- You are generally able to carry out your daily activities with little or no limitation (confirm with trial site for exact definition).
Who may not be able to join:
- You have a known allergy or serious reaction to bevacizumab, 5-FU, capecitabine, or olaparib (the drugs used in this trial).
- You have active cancer that has spread to the brain or the lining of the brain, unless it was previously treated, has been stable for at least 28 days, and you have not needed steroid medicines for it in the past 14 days.
- You currently have an infection that requires treatment with medicines given into your bloodstream (such as IV antibiotics).
- You have a known history of HIV infection.
- You have a known history of, or currently test positive for, hepatitis B or hepatitis C.
- You have a mental health condition or substance use problem that would make it difficult to take part in the study.
- You have a blood or bone marrow disorder called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or signs that suggest you may have these conditions.
- You have coughed up blood or vomited blood in the 28 days before joining the trial.
- You have a condition that makes your blood unable to clot properly (when not caused by blood-thinning medication).
- You have had significant bleeding in the 28 days before joining the trial.
- You have a serious uncontrolled medical condition, such as a recent heart attack (within the last 3 months), uncontrolled heart rhythm problems, uncontrolled seizures, or certain other serious illnesses (confirm with trial site for full list).
- Your doctor believes you should not receive bevacizumab for reasons such as very high blood pressure, a history of heart attack or stroke, serious kidney problems, a history of a hole forming in the bowel, or certain other conditions (confirm with trial site for full list).
- You have received any other cancer treatment (apart from the FOLFOX or CAPOX plus bevacizumab described above) within 28 days before joining the trial.
- You have previously been treated with olaparib or any other drug from the same class (called PARP inhibitors).
- You are currently taking certain medications that strongly or moderately affect how your body processes olaparib (a type of liver enzyme interaction), and these medications cannot be stopped — examples include itraconazole, clarithromycin, ciprofloxacin, fluconazole, and others (confirm with trial site for full list).
- You are currently taking certain other medications that can reduce how well olaparib works in your body, and these cannot be stopped — examples include phenobarbital, phenytoin, rifampicin, St John's Wort, and others (confirm with trial site for full list).
- You have had major surgery within 2 weeks before joining the trial, or you have not yet fully recovered from a recent surgery.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.