Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer

NCT04377087 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCC 19-164
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test if delaying the start of the olaparib until there is a rise in a tumor marker called CA-125 will result in a longer time until the next or different treatment for the patient's cancer. The study will also evaluate how delaying the start of maintenance therapy will affect symptoms; physical functioning; quality of life; and impact on finances.

Conditions

Ovarian Cancer

Keywords

PARP-I; BRCA mutation; Epithelial ovarian cancer (EOC); Olaparib; platinum sensitive; recurrent ovarian carcinoma; Poly ADP-Ribose Polymerase (PARP) inhibitor.

Outcome Measures

Primary Outcomes (1)

• Time to Next Therapy

  The time to next therapy from completion of platinum-based therapy for treatment of recurrence until initiation of post-olaparib treatment.

  Up to 35 months

Secondary Outcomes (8)

• Progression-free Survival (PFS)

  Up to 35 months

• Overall Survival (OS)

  Up to 35 months

• Overall Response Rate (ORR)

  Up to 35 months

• The Functional Assessment of Cancer Therapy + Ovarian-specific Scale (FACT-O)

  Up to 37 months

• PROMIS Physical Function-20a

  Up to 35 months

Study Arms (1)

Olaparib

EXPERIMENTAL

Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value.

Drug: Olaparib

Interventions

Olaparib DRUG

Olaparib is a potent oral poly (ADP-ribose) polymerase (PARP) inhibitor that induces synthetic lethality in BRCA1/2 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, which leads to disruption of cellular homeostasis and cell death.

Also known as: Lynparza™

Olaparib

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynecological cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has platinum-sensitive, recurrent ovarian, fallopian-tube or peritoneal cancer. Platinum sensitivity is defined as complete clinical remission after frontline chemotherapy lasting greater than 6 months
• Patient has completed at least 2 courses of platinum-based chemotherapy with a PR or CR as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.139 or a CA-125 response, according to Gynecological Cancer InterGroup (GCIG) criteria40
• BRCA testing required (results not needed for registration)
• ECOG performance status score of 0, 1, or 2 (See Appendix A)
• Life expectancy greater than 6 months
• Normal organ and marrow function as defined: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin (Hgb) ≥ 8 g/dL (blood transfusions to reach this amount are allowed); Serum creatinine ≤ 1.5 mg/dL; Total serum bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN
• Able to take oral medication
• Not pregnant and not breastfeeding
• Able to understand and willingness to sign a written informed consent document
• Patients must be enrolled within 8 weeks of completing last cycle of chemotherapy

You may not qualify if:

• Patient has had a prior invasive malignancy diagnosed within the last five years (except \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix or breast \[3\] has been without evidence of invasive disease for greater than 3 years)
• Patients receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
• Uncontrolled intercurrent illness that could affect their participation in the study including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements
• Impairment of gastrointestinal function or disease that may significantly alter the absorption of olaparib
• Patients who have received prior treatment with a PARP inhibitor
• History of noncompliance to medical regimens

Sponsors & Collaborators

• Sarah E Taylor: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Barbara Stadterman, MPH, CCRP
• Organization: UPMC

stadtermanbm@upmc.edu

7245532539

Study Officials

• Sarah Taylor, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 6, 2020
• Study Start: June 29, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)