Clinical trial · Interventional
A Study of MEDI-575 in Patients With Advanced Solid Malignancies
A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
NCT01102400CI-TRIAL-00009332completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-575 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: MEDI-575
Primary outcomes (1)
- measure
- Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
- timeFrame
- 30 days after the last dose of MEDI-575
Secondary outcomes (3)
- measure
- Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion
- timeFrame
- 30 days after last dose of study drug
- measure
- To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Having advanced solid malignancy for which no curative or standard therapies exist * Karnofsky performance status of ≥60 * Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part) Exclusion Criteria: * Inadequate bone marrow reserve or organ function * Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures * History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
References
Publications (1)
- DERIVEDMurakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30. PMID 26223436