First-line Olaparib Combined With Bevacizumab Maintenance Therapy

NCT05440578 | Unknown DMC FDA Drug

• 1 other identifier: ESR-20-20889-01
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.

Conditions

Ovarian Neoplasms

Keywords

tBRCA， olaparib，bevacizumab

Outcome Measures

Primary Outcomes (1)

• 1-yr PFS rate

  the investigator assessed progression-free survival (PFS) at 1 year

  12 months after date of first dose

Secondary Outcomes (4)

• 2-yr PFS rate

  24 months after date of first dose

• Median PFS

  Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

• mTFST

  Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

• Post-progression treatment

  Through study completion, an average of 1 year

Study Arms (1)

olaparib plus bevacizumab treatment group

olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.

Drug: olaparib plus bevacizumab maintenance therapy

Interventions

olaparib plus bevacizumab maintenance therapy DRUG

First-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).

olaparib plus bevacizumab treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with HGSOC who started first-line olaparib plus bevacizumab maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.

You may qualify if:

• Female Patients must be ≥18 years old at diagnosis.
• Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
• Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
• Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
• Patients who were still in CR or PR before receiving maintenance therapy
• Patients who received at least one dose of olaparib plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression

You may not qualify if:

• Patient with multiple primary cancers as reported in EMR
• Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
• Any previous treatment with PARP inhibitor.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
• Patients with symptomatic uncontrolled brain metastases.
• Any other concerns related to decreased efficacy and safety of maintenance therapy.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: July 1, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06