Clinical Trials /

Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer

NCT02301962

Description:

This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
  • Official Title: An Open Label, Multicenter, Non-Comparative, Phase IV Study of Panitumumab to Characterize Its Safety, Tolerability and Activity in Indian Subjects With Previously Treated Wild-Type RAS (KRAS and NRAS), Metastatic Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 200092
  • NCT ID: NCT02301962

Conditions

  • Cancer

Interventions

DrugSynonymsArms
PanitumumabPanitumumab arm

Purpose

This is an open label, multicenter, non-comparative, phase IV study of panitumumab monotherapy in Indian subjects with previously treated, wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS) and wild-type Neuroblastoma rat sarcoma viral (v-ras) oncogene homolog (NRAS), metastatic colorectal cancer. This study is designed to fulfil the requirement of the Indian regulatory authority to characterize the safety and tolerability of panitumumab when administered to Indian subjects with wild-type KRAS and wild-type NRAS metastatic colorectal cancer. Approximately 58 Indian subjects with previously treated wild-type KRAS and wild-type NRAS, metastatic colorectal cancer will be enrolled in order to achieve the target enrollment of 50 evaluable subjects who have received at least one dose of panitumumab. Subjects will receive panitumumab 6 milligram/kilogram (mg/kg) intravenously every 14 days until disease progression, intolerability, withdrawal of consent, or death. All subjects will be followed at 4 weeks and 8 weeks after the last administration of panitumumab, unless the treatment was discontinued due to withdrawal of consent or death of the subject.

Trial Arms

NameTypeDescriptionInterventions
Panitumumab armExperimentalSubjects will receive panitumumab 6 mg/kg intravenously as monotherapy every 14 days until disease progression, intolerability, withdrawal of consent, or death.
  • Panitumumab

Eligibility Criteria

        Inclusion Criteria:

          -  Subject or subject's legally acceptable representative has provided informed consent.

          -  Male or female >=18 years of age.

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or
             rectum.

        Metastatic disease.

          -  Wild-type KRAS (without mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and
             61], and exon 4 [codons 117 and 146]) and wild-type NRAS (without mutation in exon 2
             [codons 12 and 13], exon 3 [codons 59 and 61], and exon 4 [codons 117 and 146]) tumor
             status.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

          -  Measurable or non-measurable disease per RECIST Version 1.1.

          -  Must have failed after fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
             chemotherapy regimens for metastatic disease. Failure is defined as either disease
             progression (clinical or radiological) or intolerance to the regimen. Metastatic
             relapse within 6 months after completing adjuvant chemotherapy (with either an
             irinotecan or oxaliplatin containing regimen) will also be considered as treatment
             failure of a prior regimen for metastatic disease. Laboratory: Adequate baseline organ
             function defined by (<=7 days prior to first dose of study treatment).

          -  Hematologic function, as follows: Absolute neutrophil count (ANC) >=1.5 x 10^9/Liter
             (L), Platelet count >=75 x 10^9/L, Hemoglobin >=8.0 gram/deciliter (g/dL).

          -  Renal function, as follows: Creatinine <=1.5 x upper limit of normal (ULN).

          -  Hepatic function, as follows: Aspartate aminotransferase (AST) <=3 x ULN, Alanine
             aminotransferase (ALT) <=3 x ULN, Total Bilirubin <=1.5 x ULN.

          -  Metabolic function, as follows: Serum Magnesium within normal limits. Serum Calcium
             within normal limits. Serum Potassium within normal limits.

          -  All prior treatment related toxicities common terminology criteria for adverse events
             (CTCAE) version 4.03 <=Grade 1 at the time of enrollment.

          -  Women of childbearing potential must have a negative serum pregnancy test within 7
             days of first dose of study treatment and agree to use adequate contraception, during
             the study and for 2 months following the last dose of study treatment. Men with a
             female partner of childbearing potential must have either had a prior vasectomy or
             agree to use adequate contraception, from time of signing informed consent until 5
             months after the last dose of study treatment.

        Exclusion Criteria:

          -  History or known presence of central nervous system metastases.

          -  History of another malignancy except: Malignancy treated with curative intent and with
             no known active disease present for >=5 years prior to enrolment and felt to be at low
             risk for recurrence by the treating physician; Adequately treated non-melanomatous
             skin cancer or lentigo maligna without evidence of disease; Adequately treated
             cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial
             neoplasia without evidence of prostate cancer.

          -  Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
             chemically related to panitumumab or excipients that contraindicates their
             participation.

          -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g., panitumumab
             or cetuximab) or treatment with small molecule EGFr inhibitors (e.g., gefitinib,
             erlotinib, lapatinib).

          -  Antitumor therapy (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody
             therapy, radiotherapy), or investigational agent or therapy <=30 days before first
             dose of study treatment or not recovered from any acute toxicity.

          -  Other investigational procedure <=30 days before study entry.

          -  History of interstitial lung disease (ILD) e.g., interstitial pneumonitis, pulmonary
             fibrosis or evidence of ILD on baseline chest computer tomography.

          -  Subject previously enrolled to this study.

          -  History of keratitis, ulcerative keratitis or severe dry eye.

          -  Major surgery (e.g., requiring general anesthesia) <=30 days before first dose of
             study treatment. Subjects must have recovered from any surgery related toxicities.

          -  Minor surgical procedure (e.g., open biopsy) <=7 days before first dose of study
             treatment, or not yet recovered from prior minor surgery Note: uncomplicated placement
             of vascular access device, fine needle aspiration, thoracocentesis or paracentesis >=3
             days prior to first dose of study treatment is acceptable.

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) <=6 months prior to enrolment.

          -  History of any medical or psychiatric condition or laboratory abnormality that in the
             opinion of the investigator may increase the risk associated with the study
             participation or investigational product administration, compliance with the study
             procedures or may interfere with the interpretation of the results.

          -  Unstable pulmonary embolism, deep vein thrombosis, or other significant
             arterial/venous thromboembolic event <=30 days before first dose of study treatment.
             If on anticoagulation, subject must be on stable therapeutic dose prior to first dose
             of study treatment.

          -  Subject who is pregnant or breast feeding, or planning to become pregnant during
             treatment and within 2 months after the discontinuation of study treatment.

          -  Known positive test(s) for human immunodeficiency virus infection (testing is not
             required in the absence of clinical suspicion).

          -  Active infection requiring systemic treatment or any uncontrolled infection <=14 days
             prior to first dose of study treatment (with the exception of uncomplicated urinary
             tract infection or upper respiratory tract infection).

          -  Subject has any kind of disorder that compromises the ability of the subject to give
             written informed consent and/or to comply with study procedures or is unwilling or
             unable to comply with study requirements.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of subjects with adverse event.
Time Frame:8 months (average duration).
Safety Issue:
Description:Adverse events including medically significant laboratory changes- incidence, severity, causality and outcome will be collected from the signing of informed consent form until 8 weeks following discontinuation of study treatment due to disease progression, intolerability, withdrawal of consent or death.

Secondary Outcome Measures

Measure:Progression free survival.
Time Frame:Every 8 weeks (assessed up to average of 6 months)
Safety Issue:
Description:Progression free survival is defined as the interval between the treatment start date and the earliest date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause.
Measure:Overall Response Rate.
Time Frame:Every 8 weeks (assessed up to average of 6 months).
Safety Issue:
Description:Overall response rate is defined as the percentage of subjects with either a complete response (CR) or partial response (PR) at anytime as per RECIST version 1.1. Where CR is disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Measure:Duration of response.
Time Frame:Every 8 weeks (assessed up to average of 6 months).
Safety Issue:
Description:Duration of response is defined as the time from initial response (CR or PR) to date of disease progression per RECIST version 1.1.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GlaxoSmithKline

Trial Keywords

  • panitumumab
  • previously treated
  • metastatic colorectal cancer
  • fully human antibody
  • wild-type KRAS and wild-type NRAS

Last Updated

April 5, 2018