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NCT02301962
Phase IV Panitumumab Study in Indian Subjects With Metastatic Colorectal Cancer
Phase 4 trial testing Panitumumab in Cancer in 58 participants. Status unknown.
30 June 2021
Quick facts
| Lead sponsor | Dr. Reddy's Laboratories Limited |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 28 July 2015 |
| Primary completion | 30 June 2021 |
| Estimated completion | 31 January 2022 |
| Sites | 12 locations across India |
Drugs / interventions tested
- Panitumumab — full drug profile →
Conditions studied
- Cancer — all drugs for Cancer →
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):
-
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 -
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:
- PubMed search for NCT02301962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dr. Reddy's Laboratories Limited trials
Trials by the same sponsor.
- NCT04529499 — Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients · Phase 3 · terminated
- NCT04268771 — A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products · Phase 3 · completed
- NCT03976102 — Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular · Phase 3 · completed
- NCT03554772 — Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15 · Phase 2 · completed
- NCT03421197 — A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02301962 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Reddy's Laboratories Limited
- Last refreshed: 16 December 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing