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Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer (NIPAVect)

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ClinicalTrials.gov Identifier: NCT03983993
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
Olatunji Alese, Emory University

Brief Summary:
This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.

Condition or disease Intervention/treatment Phase
Advanced Microsatellite Stable Colorectal Carcinoma Metastatic Microsatellite Stable Colorectal Carcinoma Microsatellite Stable RAS Wild Type Stage IV Colorectal Cancer AJCC v8 MSI-H Colorectal Cancer Drug: Niraparib Biological: Panitumumab Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. Evaluate the activity of the combination of niraparib with epidermal growth factor receptor (EGFR) inhibitor panitumumab in previously treated patients with rat sarcoma gene (RAS) wild type (WT) metastatic colorectal cancer.

SECONDARY OBJECTIVES:

I. Define the toxicity profile of the combination of niraparib and panitumumab.

II. Evaluate the activity of the combination of niraparib and panitumumab in previously treated patients with metastatic colorectal cancer.

OUTLINE:

Patients receive niraparib orally (PO) once daily (QD) on days 1-28 and panitumumab intravenously (IV) over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 6 months for 2 years, and then annually for up to 5 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Niraparib in Combination With EGFR Inhibitor Panitumumab in Patients With Advanced Colorectal Cancer
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (niraparib, panitumumab)
Patients receive niraparib orally once daily on days 1-28 and 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.
Drug: Niraparib
Given PO
Other Names:
  • MK-4827
  • Zejula

Biological: Panitumumab
Given IV
Other Names:
  • ABX-EGF
  • Vectibix




Primary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: Up to 5 years post treatment ]
    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.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 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.

  2. Duration of response (DOR) [ Time Frame: 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.

  3. Progression free survival (PFS) [ Time Frame: 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.

  4. Overall survival (OS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of systemic therapy. Both microsatellite (MSI) high and stable (MSS) patients are eligible
  • Participants may have been intolerant of, progressed on, or failed at least one line of systemic chemotherapy. Patients who are currently on first line Oxaliplatin-containing chemotherapy regimen are allowed on the trial if they have remained stable or better ([partial response]PR or [complete response]CR) for at least 4 months on that line of treatment and are being considered for maintenance therapy as standard of care
  • Histologic or cytologic diagnosis of colorectal cancer
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment
  • Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study
  • Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment
  • Participant must be able to provide written informed consent

Exclusion Criteria:

  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Prior therapy with poly ADP (adenosine diphosphate) ribose polymerase (PARP) inhibitors or with EGFR inhibitors approved for the treatment of colorectal cancer (cetuximab or panitumumab)
  • Patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis during screening
  • Inability to take oral medications
  • Participant has had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
  • Participant must not have a known hypersensitivity to components or excipients of niraparib or panitumumab
  • Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Participant must not have had diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
  • Participant must not have known active, symptomatic brain or leptomeningeal metastases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983993


Contacts
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Contact: Olatunji Alese, MD 404-778-2670 oalese@emory.edu

Locations
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United States, Georgia
Emory University Hospital Midtown Not yet recruiting
Atlanta, Georgia, United States, 30308
Contact: Swathi Chinaranagari    404-686-0239    swathi.chinaranagari@emory.edu   
Contact: Shabnam Montazeri    404-686-0242    shabnam.montazeri@emory.edu   
Emory University Hospital/Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Sheena Abraham    404-778-2670    sheena.abraham@emory.edu   
Emory Saint Joseph's Hospital Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact: Alicia Escobar    678-843-7029    alicia.m.escobar@emory.edu   
Contact: Krystal Reese    678-843-5911    krystal.reese@emory.edu   
Sponsors and Collaborators
Emory University
Tesaro, Inc.
Investigators
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Principal Investigator: Olatunji Alese, MD Emory University

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Responsible Party: Olatunji Alese, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03983993     History of Changes
Other Study ID Numbers: IRB00107377
NCI-2018-02757 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship4517-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Niraparib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action