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NCT02301962

Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer

Status unknown Phase 4 Last updated 16 December 2019
What this trial tests

Phase 4 trial testing Panitumumab in Cancer in 58 participants. Status unknown.

Timeline
28 July 2015
Primary endpoint
30 June 2021
31 January 2022

Quick facts

Lead sponsorDr. Reddy's Laboratories Limited
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment58
Start date28 July 2015
Primary completion30 June 2021
Estimated completion31 January 2022
Sites12 locations across India

Drugs / interventions tested

Conditions studied

Sponsor

Dr. Reddy's Laboratories Limited

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting STAT3 in Cancer Immunotherapy.
    Zou S, Tong Q, Liu B, Huang W, et al · · 2020 · cited 787× · PMID 32972405 · DOI 10.1186/s12943-020-01258-7
  2. Unraveling the complexity of STAT3 in cancer: molecular understanding and drug discovery.
    Hu Y, Dong Z, Liu K. · · 2024 · cited 159× · PMID 38245798 · DOI 10.1186/s13046-024-02949-5

Verify or expand the search:

Other trials of Panitumumab

Trials testing the same drug.

Other recruiting trials for Cancer

Currently open trials in the same condition.

Other Dr. Reddy's Laboratories Limited trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02301962.

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