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NCT03804866
NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
Phase 2 trial testing NGR-hTNF in Ovarian Cancer in 14 participants. Completed in 1 December 2016.
1 December 2016
Quick facts
| Lead sponsor | AGC Biologics S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 1 March 2013 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 4 locations across Italy |
Drugs / interventions tested
- NGR-hTNF — full drug profile →
- Pegylated liposomal doxorubicin
- Doxorubicin (doxorubicin) — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
AGC Biologics S.p.A. — full company profile →
Who can join
18 and older, female only, with Ovarian Cancer. 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.
-
Safety according to NCI-CTCAE criteria (version 4.03)
Time frame: from the start of treatment until 28 days after last treatment
To evaluate safety profile related to NGR-hTNF
Sponsor's own description
The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Recent advanced lipid-based nanomedicines for overcoming cancer resistance.
Dechbumroong P, Hu R, Keaswejjareansuk W, Namdee K, et al · · 2024 · cited 11× · PMID 39050885 · DOI 10.20517/cdr.2024.19 -
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 NCT03804866
- 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.
- NCT03536039 — RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor · Phase 2 · completed
- 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 Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT03804866 (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/NCT03804866.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing