Clinical trial · Interventional
To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.
A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors
NCT01381341CI-TRIAL-00006577completedPhase 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)
A pharmacokinetic study to compare 2 clinical formulations of linifanib.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| linifanib | Drug | Linifanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- linifanib
- interventionNames
- Drug: linifanib
Primary outcomes (1)
- measure
- To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.
- timeFrame
- At various time points from Day 1 through Day 5 of Periods 1 and 2
- description
- Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
Secondary outcomes (3)
- measure
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
- timeFrame
- Throughout the study
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Age is greater than or equal to 18 years. 2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC). 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. 4. Subject must have adequate bone marrow, renal and hepatic function as follows: * Bone Marrow: Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (1.5 X 10\^9/L); Platelets \>= 75,000/mm\^3 (75 X 10\^9/L); Hemoglobin \>= 9.0 g/dL (1.4 mmol/L) * Renal function: serum creatinine \<= 2.0 mg/dL (0.81 mmol/L); * Hepatic function: AST and ALT \<= 1.5 X ULN unless liver metastases are present, then AST and ALT \<= 5.0 X ULN; bilirubin \<= 1.5 mg/dL (0.026 mmol/L) 5. Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) \</= 1.5. Exclusion Criteria 1. Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy. 2. Subject has undergone major surgery within 21 days of Period 1, Study Day 1. 3. Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1). 4. Current enrollment in another clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.