Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
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.
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.

 All adverse events occurring from signing of informed consent form until 8 weeks after last
 dose of panitumumab will be recorded. All Serious Adverse Events (SAE) considered related to
 panitumumab by the investigator or the sponsor will be followed until the event resolves, or
 is considered stable or until the subject is lost to follow-up or withdraws consent.
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.