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Olaparib Maintenance Therapy for Ovarian Cancer (SOLO-1 Trial)

Phase 3

Waitlist Available

Led By Prof Paul DiSilvestro, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal)

Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.

Must not have

Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment

Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. dco: 17 may 2018

Awards & highlights

Pivotal Trial

Summary

This trial looked at olaparib as a possible treatment for ovarian cancer in patients who had the BRCA gene mutation.

Who is the study for?

This trial is for women with newly diagnosed high-grade ovarian cancer (FIGO stage III-IV) that have specific harmful mutations in BRCA genes. They should have responded well to first-line platinum-based chemotherapy and undergone debulking surgery if needed. Women with stable or worsening disease post-chemotherapy, early-stage cancer, multiple surgeries before the study, or previous chemo for abdominal tumors are excluded.

What is being tested?

The trial tests Olaparib tablets as a maintenance therapy for patients who've had a positive response to initial chemotherapy. It's aimed at preventing cancer from coming back by targeting BRCA mutations which are common in high-grade ovarian cancers.

What are the potential side effects?

While not specified here, common side effects of Olaparib can include nausea, fatigue, anemia (low red blood cell counts), vomiting, diarrhea, decreased appetite and taste changes. More serious but less common side effects may involve lung problems and risk of developing other cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with advanced ovarian, peritoneal, or fallopian tube cancer with a BRCA mutation and have finished first-line platinum chemotherapy.

Select...

I've had surgery aimed at removing as much cancer as possible.

Select...

I have a harmful BRCA1 or BRCA2 mutation.

Select...

I've had surgery to remove as much cancer as possible.

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I am a woman with advanced ovarian, peritoneal, or fallopian tube cancer with a BRCA mutation and have finished first-line platinum chemotherapy.

Select...

I have a harmful BRCA1 or BRCA2 mutation.

Select...

My cancer responded well to the first round of chemotherapy without signs of getting worse.

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I have completed a first round of platinum-based chemotherapy before being considered for this trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer did not improve but also did not worsen after my first chemotherapy.

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I was previously treated for early-stage ovarian, fallopian tube, or peritoneal cancer.

Select...

My cancer is in an early stage (Stage I to IIC).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 12 weeks following treatment discontinuation. analysis performed with dco: 17may2018. further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 12 weeks following treatment discontinuation. analysis performed with dco: 17may2018. further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 12 weeks following treatment discontinuation. analysis performed with dco: 17may2018. further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Secondary study objectives

Ovary

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Olaparib tablets p.o. 300mg twice dailyExperimental Treatment1 Intervention

Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Group II: Placebo tablets p.o. twice dailyPlacebo Group1 Intervention

0 / 11Eligibility criteria met