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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival. | 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. | Every 8 weeks (assessed up to average of 6 months) |
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Inclusion Criteria:
Metastatic disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sachin Joshi, MPharm | Contact | 040-48796000 | 6017 | sachinsjoshi@drreddys.com |
| Dr Agam Shah, MD | Contact | 040-48796000 | 6019 | agam.shah@drreddys.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Lalit Lakhwani, MD | Dr. Reddys Laboratories Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRL Investigational Site | Recruiting | Vijayawada | Andhra Pradesh | 520002 | India |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Overall Response Rate. |
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). |
| Every 8 weeks (assessed up to average of 6 months). |
| Duration of response. | Duration of response is defined as the time from initial response (CR or PR) to date of disease progression per RECIST version 1.1. | Every 8 weeks (assessed up to average of 6 months). |
| DRL Investigational Site | Not yet recruiting | Mumbai | Maharashtra | 400012 | India |
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| DRL Investigational Site | Recruiting | Nagpur | Maharashtra | 440026 | India |
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| DRL Investigational Site | Recruiting | Nashik | Maharashtra | 422004 | India |
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| DRL Investigational Site | Recruiting | Nashik | Maharashtra | 422005 | India |
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| DRL Investigational Site | Recruiting | Ludhiana | Punjab | 141010 | India |
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| DRL Investigational Site | Recruiting | Jaipur | Rajasthan | 302 020 | India |
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| DRL Investigational Site | Recruiting | Madurai | Tamil Nadu | 625107 | India |
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| DRL Investigational Site | Recruiting | Hyderabad | Telangana | 500004 | India |
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| DRL Investigational Site | Active, not recruiting | Kolkata | West Bengal | 700156 | India |
| DRL Investigational Site | Not yet recruiting | New Delhi | 110029 | India |
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| DRL Investigational Site | Recruiting | New Delhi | 110060 | India |
|
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |