Trial Outcomes & Findings for A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma (NCT NCT03840967)

Last Updated: 2024-06-04

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the percentage of patients who reached CR or PR by RECIST 1.1.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to maximum of 5 months.

Results posted on

2024-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Niraparib Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Niraparib n=14 Participants Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	1 Participants n=5 Participants
Race (NIH/OMB) White	13 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
Region of Enrollment United States	14 participants n=5 Participants
ECOG Performance Status ECOG = 0	3 Participants n=5 Participants
ECOG Performance Status ECOG = 1	11 Participants n=5 Participants
Smoking Status Never	5 Participants n=5 Participants
Smoking Status Former	7 Participants n=5 Participants
Smoking Status Current	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to maximum of 5 months.

Population: Out of 14 patients, three patients were not evaluable for best response.

Outcome measures

Outcome measures
Measure	Niraparib n=11 Participants Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Objective Response Rate (ORR)	0 Percentage of participants

SECONDARY outcome

Timeframe: AE had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 6 months.

Number of participants with treatment related adverse events are reported by CTCAEv5 term and grade.

Outcome measures

Outcome measures
Measure	Niraparib n=14 Participants Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Adverse Events Hyponatremia	1 Participants
Adverse Events Sinus tachycardia	1 Participants
Adverse Events Anemia	7 Participants
Adverse Events Fatigue	7 Participants
Adverse Events Platelet count decreased	7 Participants
Adverse Events Nausea	6 Participants
Adverse Events Headache	5 Participants
Adverse Events White blood cell decreased	5 Participants
Adverse Events Anorexia	3 Participants
Adverse Events Constipation	3 Participants
Adverse Events Weight loss	3 Participants
Adverse Events Abdominal pain	2 Participants
Adverse Events Diarrhea	2 Participants
Adverse Events Dizziness	2 Participants
Adverse Events Dyspepsia	2 Participants
Adverse Events Hypocalcemia	2 Participants
Adverse Events Lymphocyte count decreased	2 Participants
Adverse Events Neutrophil count decreased	2 Participants
Adverse Events Vomiting	2 Participants
Adverse Events Arthralgia	1 Participants
Adverse Events Aspartate aminotransferase increased	1 Participants
Adverse Events Cough	1 Participants
Adverse Events Dry mouth	1 Participants
Adverse Events Dry skin	1 Participants
Adverse Events Dysgeusia	1 Participants
Adverse Events Dyspnea	1 Participants
Adverse Events Hypercalcemia	1 Participants

SECONDARY outcome

Timeframe: Up to a maximum of 5 months.

Population: Out of 14 patients, three patients were not evaluable for PFS.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from treatment start until disease progression met by RECIST 1.1 or death from any cause.

Outcome measures

Outcome measures
Measure	Niraparib n=11 Participants Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Progression Free Survival (PFS)	1.8 Months Interval 1.0 to 3.7

SECONDARY outcome

Timeframe: Up to maximum of 5 months.

Population: Out of 14 patients, three patients were not evaluable for DCR.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease control rate (DCR) is defined as the percentage of evaluable patients with stable disease (SD) for 8 weeks, or partial response (PR), or complete response (CR) according to RECIST 1.1.

Outcome measures

Outcome measures
Measure	Niraparib n=11 Participants Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Disease Control Rate	18.2 Percentage of participants Interval 2.3 to 51.8

Adverse Events

Niraparib

Serious events: 3 serious events

Other events: 13 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Niraparib n=14 participants at risk Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Respiratory, thoracic and mediastinal disorders ASPIRATION	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Infections and infestations SEPSIS	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders VOMITING	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.

Other adverse events

Other adverse events
Measure	Niraparib n=14 participants at risk Niraparib: Niraparib will be administered as a flat-fixed daily dose depending on weight and platelet count. Subjects will take orally on a daily basis for 28 days. Each cycle = 28 days
Gastrointestinal disorders ABDOMINAL PAIN	21.4% 3/14 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations ALKALINE PHOSPHATASE INCREASED	35.7% 5/14 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Skin and subcutaneous tissue disorders ALOPECIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Blood and lymphatic system disorders ANEMIA	71.4% 10/14 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders ANOREXIA	28.6% 4/14 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Psychiatric disorders ANXIETY	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	28.6% 4/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Musculoskeletal and connective tissue disorders BACK PAIN	21.4% 3/14 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations BLOOD BILIRUBIN INCREASED	7.1% 1/14 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
General disorders CHILLS	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders CONSTIPATION	42.9% 6/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Respiratory, thoracic and mediastinal disorders COUGH	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations CREATININE INCREASED	21.4% 3/14 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders DIARRHEA	21.4% 3/14 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Nervous system disorders DIZZINESS	21.4% 3/14 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders DRY MOUTH	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Skin and subcutaneous tissue disorders DRY SKIN	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Nervous system disorders DYSGEUSIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders DYSPEPSIA	21.4% 3/14 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders DYSPHAGIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Blood and lymphatic system disorders EOSINOPHILIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
General disorders FATIGUE	71.4% 10/14 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
General disorders FEVER	21.4% 3/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Nervous system disorders HEADACHE	57.1% 8/14 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Infections and infestations HEPATIC INFECTION	7.1% 1/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPERCALCEMIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPOALBUMINEMIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPOCALCEMIA	21.4% 3/14 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPOGLYCEMIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPOKALEMIA	14.3% 2/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPOMAGNESEMIA	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Metabolism and nutrition disorders HYPONATREMIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Vascular disorders HYPOTENSION	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	7.1% 1/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Psychiatric disorders INSOMNIA	21.4% 3/14 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations INVESTIGATIONS - OTHER, SPECIFY	14.3% 2/14 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Infections and infestations LUNG INFECTION	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations LYMPHOCYTE COUNT DECREASED	14.3% 2/14 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Nervous system disorders MEMORY IMPAIRMENT	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders MUCOSITIS ORAL	7.1% 1/14 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders NAUSEA	50.0% 7/14 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations NEUTROPHIL COUNT DECREASED	21.4% 3/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
General disorders PAIN	14.3% 2/14 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations PLATELET COUNT DECREASED	57.1% 8/14 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders RECTAL HEMORRHAGE	7.1% 1/14 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Cardiac disorders SINUS TACHYCARDIA	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	28.6% 4/14 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Renal and urinary disorders URINARY RETENTION	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Infections and infestations URINARY TRACT INFECTION	7.1% 1/14 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Gastrointestinal disorders VOMITING	21.4% 3/14 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations WEIGHT LOSS	28.6% 4/14 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.
Investigations WHITE BLOOD CELL DECREASED	42.9% 6/14 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 24 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 6 months.

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place