Clinical trial · Interventional
Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
NCT01170897CI-TRIAL-00013598completedPhase 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)
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
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
- Maximally Tolerated Dose
- description
- To identify the maximally tolerated dose (MTD) of PEGPH20.
- interventionNames
- Drug: PEGPH20
Primary outcomes (2)
- measure
- Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer
- timeFrame
- To be evaluable for MTD determination, a patient must have completed the Cycle 1 study drug doses and the associated assessments for safety and toxicity evaluation
- description
- The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)
- measure
- Safety endpoints including assessment of both serious and non-serious AEs
- timeFrame
- From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written, signed, IRB-approved informed consent form. * Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy. * One or more tumors measurable by RECIST criteria. * Karnofsky performance status ≥ 70%. * Ejection fraction ≥ 50%, determined by echocardiogram. * Life expectancy at least 3 months. * Age ≥ 18 years. * Acceptable organ function; normal hepatic, renal and hematopoietic function. * Negative serum or urine pregnancy test result in women of childbearing potential. Exclusion Criteria: * Known brain metastasis. * New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy. * Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. * Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy. * Heparin therapy. * Known infection with HIV, hepatitis B, or hepatitis C. * Known allergy to hyaluronidase. * Women currently breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.