Phase 4 study of Panitumumab in advanced colorectal cancer

Phase 4

• Conditions: Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: null- metastatic colorectal cancer

• Registration Number: CTRI/2014/08/004843
• Lead Sponsor: Dr Reddys Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subject or subjectâ??s legally acceptable representative has provided informed consent

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

ï?· 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.

ECOG performance status of 0, 1 or 2 (see Appendix 3)

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

ï?· 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

Hematologic function, as follows:

ï?· Absolute neutrophil count (ANC) >= 1.5 x 109/L

ï?· Platelet count >= 75 x 109/L

ï?· Hemoglobin >= 8.0 g/dL

Renal function, as follows:

ï?· Creatinine <= 1.5 x upper limit of normal (ULN)

Hepatic function, as follows:

ï?· Aspartate aminotransferase (AST) <= 3 x ULN

ï?· Alanine aminotransferase (ALT) <= 3 x ULN

ï?· Total Bilirubin <= 1.5 x ULN

Metabolic function, as follows:

ï?· Serum Magnesium within normal limits

ï?· Serum Calcium within normal limits

ï?· Serum Potassium within normal limits

All prior treatment related toxicities 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:

ï?· 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

ï?· Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease

ï?· Adequately treated cervical carcinoma in situ without evidence of disease

ï?· 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-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 CT

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 c

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of panitumumab in the labelled dose in 50 subjects with previously treated wild-type KRAS and wild-type NRAS metastatic colorectal cancerTimepoint: Laboratory evaluations every 4 weeks, Physical examination every 2 weeks, adverse event monitoring through out the study duration.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS), Overall response rate (ORR) and Duration of responseTimepoint: Assessments every 8 weeks