Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer

NCT02301962 | Unknown Phase 4

• 1 other identifier: DRL-INDG02-PAN/2018
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse event.

  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.

  8 months (average duration).

Secondary Outcomes (3)

• Progression free survival.

  Every 8 weeks (assessed up to average of 6 months)

• Overall Response Rate.

  Every 8 weeks (assessed up to average of 6 months).

• Duration of response.

  Every 8 weeks (assessed up to average of 6 months).

Study Arms (1)

Panitumumab arm

EXPERIMENTAL

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

Drug: Panitumumab

Interventions

Panitumumab DRUG

Panitumumab is available as a concentrate for solution for infusion (sterile concentrate). It is a colorless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles. Each milliliter (mL) of concentrate contains 20 mg panitumumab. Each vial contains 100 mg of panitumumab in 5 mL.

Panitumumab arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• Amgen: collaborator

Study Sites (12)

DRL Investigational Site

Vijayawada, Andhra Pradesh, 520002, India

RECRUITING

DRL Investigational Site

Mumbai, Maharashtra, 400012, India

NOT YET RECRUITING

DRL Investigational Site

Nagpur, Maharashtra, 440026, India

RECRUITING

DRL Investigational Site

Nashik, Maharashtra, 422004, India

RECRUITING

DRL Investigational Site

Nashik, Maharashtra, 422005, India

RECRUITING

DRL Investigational Site

Ludhiana, Punjab, 141010, India

RECRUITING

DRL Investigational Site

Jaipur, Rajasthan, 302 020, India

RECRUITING

DRL Investigational Site

Madurai, Tamil Nadu, 625107, India

RECRUITING

DRL Investigational Site

Hyderabad, Telangana, 500004, India

RECRUITING

DRL Investigational Site

Kolkata, West Bengal, 700156, India

ACTIVE NOT RECRUITING

DRL Investigational Site

New Delhi, 110029, India

NOT YET RECRUITING

DRL Investigational Site

New Delhi, 110060, India

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dr Lalit Lakhwani, MD

  Dr. Reddys Laboratories Limited

  STUDY DIRECTOR

Central Study Contacts

Sachin Joshi, MPharm

CONTACT

040-48796000; sachinsjoshi@drreddys.com

Dr Agam Shah, MD

CONTACT

040-48796000; agam.shah@drreddys.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: July 28, 2015
• Primary Completion: June 30, 2021
• Study Completion: January 31, 2022
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

IN (12)