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NCT00483080
NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens
Phase 2 trial testing NGR-hTNF in Colorectal Cancer (CRC) in 46 participants. Completed in 1 April 2013.
1 June 2009
Quick facts
| Lead sponsor | AGC Biologics S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 December 2006 |
| Primary completion | 1 June 2009 |
| Estimated completion | 1 April 2013 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- NGR-hTNF — full drug profile →
Conditions studied
- Colorectal Cancer (CRC) — all drugs for Colorectal Cancer (CRC) →
Sponsor
AGC Biologics S.p.A. — full company profile →
Who can join
Adults 18 to 80, any sex, with Colorectal Cancer (CRC). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Progression Free Survival (PFS)
Time frame: during the study
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
Sponsor's own description
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Peptide-Drug Conjugates: A New Hope for Cancer Management.
Chavda VP, Solanki HK, Davidson M, Apostolopoulos V, et al · · 2022 · cited 59× · PMID 36364057 · DOI 10.3390/molecules27217232 -
Engineering cytokines for cancer immunotherapy: a systematic review.
Fu Y, Tang R, Zhao X. · · 2023 · cited 36× · PMID 37483629 · DOI 10.3389/fimmu.2023.1218082 -
Potential theranostics of circulating tumor cells and tumor-derived exosomes application in colorectal cancer.
Vafaei S, Roudi R, Madjd Z, Aref AR, et al · · 2020 · cited 19× · PMID 32655320 · DOI 10.1186/s12935-020-01389-3 -
Colorectal Cancer at the Crossroads: The Good, the Bad, and the Future of Platinum-Based Drugs.
Kee JX, Yau JNN, Kumar Muthuramalingam RP, Wang X, et al · · 2025 · cited 6× · PMID 40985211 · DOI 10.1021/acs.chemrev.5c00041 -
Vascular Disruption Therapy as a New Strategy for Cancer Treatment.
Gómez-Escudero J, Berlana-Galán P, Guerra-Paes E, Torre-Cea I, et al · · 2025 · cited 1× · PMID 41155375 · DOI 10.3390/ijms262010085 -
Innovative design concepts in tumor-targeting peptide-drug conjugates: Insights into emerging applications.
Tan R, Yang Z, Xie J, Wu Z, et al · · 2026 · cited 1× · PMID 40033748 · DOI 10.1097/cm9.0000000000003438
Verify or expand the search:
- PubMed search for NCT00483080
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NGR-hTNF
Trials testing the same drug.
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- NCT00483509 — Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma · Phase 2 · completed
- NCT00305084 — Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors · Phase 1 · completed
Other recruiting trials for Colorectal Cancer (CRC)
Currently open trials in the same condition.
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- NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
- NCT07106892 — Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects Wit · Phase 2 · recruiting
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- NCT07046468 — Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer · recruiting
Other AGC Biologics S.p.A. trials
Trials by the same sponsor.
- NCT04097301 — Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma · Phase 1, PHASE2 · terminated
- NCT00914628 — Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia · Phase 3 · terminated
- NCT00483509 — Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma · Phase 2 · completed
- NCT00305084 — Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors · Phase 1 · 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 NCT00483080 (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 AGC Biologics S.p.A.
- Last refreshed: 14 January 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/NCT00483080.
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