Clinical trial · Interventional
Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors
A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors
- 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 open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.
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/Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PHA-793887 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose-Escalation
- interventionNames
- Drug: PHA-793887
Primary outcomes (1)
- measure
- Determination of Dose Limiting Toxicities and Maximum Tolerated Dose
- timeFrame
- First cycle
Secondary outcomes (3)
- measure
- Assessment of Adverse Events (based on CTCAE version 3.0)
- timeFrame
- All cycles
- measure
- Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced/metastatic solid tumors for which no standard therapy exists * ECOG (WHO) performance status 0-1 * Life expectancy of at least 3 months * Age ≥ 18 years * Adequate liver, pancreas and renal function * Acceptable hematologic status * Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1 * Treatment with surgery, chemotherapy, or investigational therapy must be completed at least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin C and liposomal doxorubicin) * Prior radiation therapy allowed in no more than 25% of bone marrow reserve * Men and women of child-producing potential must agree upon the use of effective contraceptive methods Exclusion Criteria: * In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * Known brain metastases * Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Pregnant or breast feeding women * Known infection with HIV, active hepatitis B or hepatitis C * Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation * History of pancreatitis or disorders making the patient at risk of pancreatitis * Previous history or current presence of neurological disorders * Patients with pre-existing symptoms of peripheral neuropathy not related to prior anticancer therapy(ies) * Concomitant treatment that may be associated with peripheral neuropathy * Other severe concurrent conditions that could compromise protocol objectives.
References
Publications (0)
Data not yet available