Trial Outcomes & Findings for Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer (NCT NCT04377087)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 35 months

Results posted on

2024-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Olaparib Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib n=3 Participants Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Age, Continuous	63.7 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 35 months

Population: All enrolled participants that received a subsequent therapy.

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

Outcome measures

Outcome measures
Measure	Olaparib n=2 Participants Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Time to Next Therapy Patient 2	1 months
Time to Next Therapy Patient 3	3 months

SECONDARY outcome

Timeframe: Up to 35 months

Population: All enrolled participants that had radiologically confirmed disease progression.

Progression-free survival (PFS) defined as time from enrollment until detected recurrence or progression of disease, via Response Evaluation Criteria in Solid Tumors , or death from any cause.. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Olaparib n=1 Participants Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Progression-free Survival (PFS)	3 months

SECONDARY outcome

Timeframe: Up to 35 months

Population: Participants that experienced the event of death.

Overall survival as defined as the time from enrollment to death from any cause.

Outcome measures

Outcome measures
Measure	Olaparib n=1 Participants Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Overall Survival (OS)	15 months

SECONDARY outcome

Timeframe: Up to 35 months

Population: Zero treated patients that experienced a radiologically measurable complete or partial response per RECIST v1.1

The proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 37 months

Population: Longitudinal assessments unavailable per limited enrollment. No data collected.

Health-related quality of life measured via The Functional Assessment of Cancer Therapy + Ovarian-specific scale (FACT-O). The FACT-O includes a list of statements that \[other\] people with ovarian cancer have said are important. The patient is asked to circle or mark one number per line to indicate their response as it applies to the prior 7 days. The scoring ranges from 0 (Not at all) to 4 (very much).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 35 months

Population: Longitudinal assessments unavailable per limited enrollment. No data collected.

Physical function assessed through the PROMIS Physical Function-20a assesses self-reported performance of physical activities. The PROMIS includes a list of statements related to physical performance, with scores of 0 (Always) to 5 (Rarely).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 35 months

Population: Longitudinal assessments unavailable per limited enrollment. No data collected.

The Assessment of Survivor Concerns (ASC) Worry Subscale and Impact of Event Scale (IES-R) will be used to measure worry and distress. The assessment includes a list of statements related to worry and stress experience during the patients prior, with responses ranging from 0 (Not at all) to 4 (Extremely). This assessment includes three subscales, the Intrusion subscale, the Avoidance subscale and the Hyperarousal subscale, which are each related to specific questions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 35 months

Population: Longitudinal assessments unavailable per limited enrollment. No data collected.

Financial toxicity measured through (a) monetary measure using the Modified Collection of Indirect and Non-medical Direct Costs (COIN), (b) objective measure of financial burden assessed using Barrera et al's Economic Hardship questionnaire, and (c) subjective measure of financial distress will be gauged using the Comprehensive Score for Financial Toxicity (COST Measure).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 35 months

Population: Treated patients that experienced adverse events related to study treatment.

The number of patients that experience Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 that were determined to be possibly, probably or definitely related to study treatment.

Outcome measures

Outcome measures
Measure	Olaparib n=2 Participants Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Adverse Events Possibly, Probably or Definitely Related to Treatment Pruritus (non-serious)	1 participants
Adverse Events Possibly, Probably or Definitely Related to Treatment Lymphocyte count decreased (non-serious)	1 participants
Adverse Events Possibly, Probably or Definitely Related to Treatment Fatigue (non-serious)	1 participants

Adverse Events

Olaparib

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olaparib n=3 participants at risk Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value. Olaparib: 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.
Vascular disorders Hypertension	33.3% 1/3 • Adverse Events collected for up to 35 months
Renal and urinary disorders Renal calculi	33.3% 1/3 • Adverse Events collected for up to 35 months
Metabolism and nutrition disorders Hypermagnesemia	33.3% 1/3 • Adverse Events collected for up to 35 months
Investigations Lymphocyte count decreased	33.3% 1/3 • Adverse Events collected for up to 35 months
Investigations Alkaline phosphatase increased	33.3% 1/3 • Adverse Events collected for up to 35 months
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Adverse Events collected for up to 35 months
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	33.3% 1/3 • Adverse Events collected for up to 35 months
Cardiac disorders Sinus bradycardia	33.3% 1/3 • Adverse Events collected for up to 35 months
General disorders Fatigue	33.3% 1/3 • Adverse Events collected for up to 35 months

Additional Information

Barbara Stadterman, MPH, CCRP

UPMC

Phone: 7245532539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place