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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.

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

SOLO-1 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.Check my eligibility

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.See study design

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.

SOLO-1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Select...

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.

Select...

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

SOLO-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

SOLO-1 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK

41 Previous Clinical Trials

15,691 Total Patients Enrolled

7 Trials studying Ovarian Cancer

2,679 Patients Enrolled for Ovarian Cancer

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,336 Total Patients Enrolled

48 Trials studying Ovarian Cancer

23,850 Patients Enrolled for Ovarian Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,121 Total Patients Enrolled

42 Trials studying Ovarian Cancer

6,600 Patients Enrolled for Ovarian Cancer

Media Library

Olaparib 300mg tablets 2023 Treatment Timeline for Medical Study. Trial Name: NCT01844986 — Phase 3

Frequently Asked Questions

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

In how many different medical centers is this clinical trial taking place?

"88 patients have already been recruited for this trial from various locations, including Durham, Oakland and New york."

Answered by AI

Are octogenarians able to partake in this research project?

"As long as patients are aged 18 or older, and not 130 years or older, they meet the age criteria for this trial."

Answered by AI

Has the FDA cleared Olaparib 300mg tablets for public consumption?

"Olaparib 300mg tablets have been studied in multiple clinical trials, supporting its efficacy and safety. Our team at Power gives it a score of 3 on our safety scale."

Answered by AI

What are the most similar investigations to the Olaparib 300mg tablet study?

"At the moment, there are 197 clinical trials underway that are studying Olaparib 300mg tablets. 27 of those live clinical trials are in Phase 3. Although most of the trials for Olaparib 300mg tablets are taking place in Houston, Texas, there are 9317 locations running trials for this treatment across the globe."

Answered by AI

How many people can sign up for this experiment at most?

"As of now, this trial is not seeking more participants. The posting for this clinical study was made on 8/26/2013 and updated last on 7/27/2022. If you are looking for other trials, 567 studies involving patients with partial response and 197 Olaparib 300mg tablet trials are currently underway and actively enrolling individuals."

Answered by AI

Does this medical study represent a new development in research?

"There are 197 ongoing trials for Olaparib 300mg tablets in 59 countries and 1462 cities. The first trial, which was Phase 1 and completed drug approval in 2005, had 98 participants and was sponsored by AstraZeneca. 63 studies have been conducted since then."

Answered by AI

Are there any empty slots in this research project for new participants?

"The clinical trial isn't recruiting patients at the moment, however this could change in the future. According to information found on clinicaltrials.gov, the trial was posted on 8/26/2013 and last edited on 7/27/2022. There are presently 764 other trials looking for patients."

Answered by AI

What condition is Olaparib 300mg most effective in treating?

"Olaparib 300mg tablets can be used as part of treatment plans for patients with advance directives, malignant neoplasm of ovary, and primary peritoneal cancer."

Answered by AI

Might I be eligible to take part in this research?

"This study is open to 450 people who have partial response and meet the following age, gender, and disease criteria: -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).-Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post"

Answered by AI