NCT02301962

Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	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.

Timeline

• Start date: 2015-07-28
• Primary completion: 2021-06-30
• Completion: 2022-01-31
• First posted: 2014-11-26
• Last updated: 2019-12-16

Locations

12 sites across 1 country: India