Trial Outcomes & Findings for Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer (NCT NCT03983993)

Last Updated: 2026-01-05

Results Overview

The efficacy, as measured by clinical benefit rate (CBR), will be assessed for the total number of patients enrolled. CBR = (Complete Response + Partial Response + Stable Disease \[CR +PR + SD\] rate. Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

3 years and 7 months post treatment

Results posted on

2026-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Niraparib, Panitumumab) Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Niraparib, Panitumumab) n=25 Participants Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Age, Continuous	58.5 years STANDARD_DEVIATION 12 • n=9667 Participants
Sex: Female, Male Female	12 Participants n=9667 Participants
Sex: Female, Male Male	13 Participants n=9667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9667 Participants
Race (NIH/OMB) Asian	3 Participants n=9667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9667 Participants
Race (NIH/OMB) Black or African American	5 Participants n=9667 Participants
Race (NIH/OMB) White	16 Participants n=9667 Participants
Race (NIH/OMB) More than one race	0 Participants n=9667 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9667 Participants
Region of Enrollment United States	25 participants n=9667 Participants

PRIMARY outcome

Timeframe: 3 years and 7 months post treatment

Outcome measures

Outcome measures
Measure	Treatment (Niraparib, Panitumumab) n=24 Participants Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Clinical Benefit Rate (CBR)	83.3 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years post treatment

Objective response rate (ORR) is defined as the percentage of patients with complete response (CR) or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.

Outcome measures

Outcome measures
Measure	Treatment (Niraparib, Panitumumab) n=24 Participants Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Objective Response Rate (ORR)	25 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 years post treatment

Duration of response (DOR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until the time of first documentation of disease progression, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post treatment

For progression free survival (PFS), progression or death from any cause will be defined as the event. Progression will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review. Patients will be censored at time of last follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Niraparib, Panitumumab) n=24 Participants Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Progression Free Survival (PFS)	5.6 months Interval 3.7 to 6.9

SECONDARY outcome

Timeframe: Up to 5 years post treatment

For overall survival (OS), death from any cause will be defined as the event. Patients will be censored at time of last follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Niraparib, Panitumumab) n=24 Participants Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Overall Survival (OS)	20.9 months Interval 9.2 to Median Overall Survival- 20.9 months (95% CI: 9.2, NR). The NA means the upper bound of 95%CI of median OS is not estimatable by Kaplan-Meier method due to not having a sufficient number of participants with events.

Adverse Events

Treatment (Niraparib, Panitumumab)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Niraparib, Panitumumab) n=24 participants at risk Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Niraparib: Given PO Panitumumab: Given IV
Skin and subcutaneous tissue disorders Rash	70.8% 17/24 • 5 years after study enrollment
Blood and lymphatic system disorders Anemia	33.3% 8/24 • 5 years after study enrollment
General disorders Fatigue	33.3% 8/24 • 5 years after study enrollment
Gastrointestinal disorders Constipation	29.2% 7/24 • 5 years after study enrollment
Investigations Aspartate aminotransferase increased	20.8% 5/24 • 5 years after study enrollment
Investigations Hypokalemia	20.8% 5/24 • 5 years after study enrollment
Gastrointestinal disorders Oral mucositis	20.8% 5/24 • 5 years after study enrollment
Blood and lymphatic system disorders Thrombocytopenia	20.8% 5/24 • 5 years after study enrollment
Investigations Alkaline Phosphatase increased	16.7% 4/24 • 5 years after study enrollment
Skin and subcutaneous tissue disorders Dry Skin	16.7% 4/24 • 5 years after study enrollment
Blood and lymphatic system disorders Leukopenia	16.7% 4/24 • 5 years after study enrollment
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 3/24 • 5 years after study enrollment
Gastrointestinal disorders Diarrhea	12.5% 3/24 • 5 years after study enrollment
Investigations Hyponatremia	12.5% 3/24 • 5 years after study enrollment
Skin and subcutaneous tissue disorders Nail changes	12.5% 3/24 • 5 years after study enrollment
Gastrointestinal disorders Abdominal Pain	8.3% 2/24 • 5 years after study enrollment
Hepatobiliary disorders Elevated bilirubin	8.3% 2/24 • 5 years after study enrollment
Respiratory, thoracic and mediastinal disorders Cough	8.3% 2/24 • 5 years after study enrollment
Nervous system disorders Dizziness	8.3% 2/24 • 5 years after study enrollment
Gastrointestinal disorders Dyspepsia	8.3% 2/24 • 5 years after study enrollment
Infections and infestations Fever	8.3% 2/24 • 5 years after study enrollment
Skin and subcutaneous tissue disorders Purpura	8.3% 2/24 • 5 years after study enrollment
Gastrointestinal disorders Vomiting	8.3% 2/24 • 5 years after study enrollment
Gastrointestinal disorders Weight loss	8.3% 2/24 • 5 years after study enrollment
Gastrointestinal disorders Sore throat	8.3% 2/24 • 5 years after study enrollment
Gastrointestinal disorders Gastroesophageal reflux	8.3% 2/24 • 5 years after study enrollment

Additional Information

Olatunji Alese

Emory University

Phone: 404-778-6639

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place