Clinical trial · Interventional
Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Given Intravenously to Patients With Advanced Solid Tumors
NCT00834704CI-TRIAL-00009838PEGcompletedPhase 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)
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEGPH20 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- Dose determination
- interventionNames
- Drug: PEGPH20
Primary outcomes (1)
- measure
- To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.
- timeFrame
- 28 days
Secondary outcomes (4)
- measure
- To determine the pharmacokinetics (PK) of PEGPH20
- timeFrame
- 28 days
- measure
- To determine the dose-limiting toxicities (DLTs) of PEGPH20.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment. * One or more tumors measurable by RECIST criteria. * Karnofsky performance status ≥ 70%. * Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery. * Negative serum or urine pregnancy test result in women of childbearing potential. * For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation. Exclusion Criteria: * Brain metastasis. * New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy. * Known allergy to hyaluronidase. * Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. * Women currently breast feeding. * Concurrent participation in any other interventional therapeutic study.
References
Publications (0)
Data not yet available
No reference posted for this study.