Clinical trial · Interventional
A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.
Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
NCT01286974CI-TRIAL-00008054terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early, Sponsor Decision
Summary
Brief summary (as posted)
A pharmacokinetic study to access how the body absorbs and removes linifanib in male 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]linifanib | Drug | Linifanib | ALIAS |
| ABT-869, linifanib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADME
- description
- \[14C\]linifanib
- interventionNames
- Drug: [14C]linifanib
- type
- EXPERIMENTAL
- label
- Extension
- description
- linifanib
- interventionNames
- Drug: ABT-869, linifanib
Primary outcomes (2)
- measure
- Pharmacokinetic Profile
- timeFrame
- Various timepoints from Day 1 through approximately Day 9
- description
- Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Subject must be \>/= 18 years of age. * Subject must have a histologically or cytologically confirmed non-hematologic malignancy. * Eastern cooperative Oncology Group (ECOG) Performance Score of 0 to 2. * Subject must have adequate bone marrow, renal and hepatic function. * Subject must have Partial Thromboplastin Time (PTT) \</= 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \</= 1.5. * Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent. Exclusion Criteria * Subject has received previous administration of a radiolabeled research substance within 12 months prior to Study Day 1 or exposure to significant radiation (e.g., barium meal, etc.) within the past 3 months or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1. * Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a period defined by 5 half-lives, whichever is shorter, prior to Study Day 1. * Subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g., rifampin) of cytochrome P450 3A (CYP3A) within 1 month prior to Study Day 1. * Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy. * Subject has undergone major surgery within 21 days of Study Day 1. * The subject has brain or meningeal metastases. * The subject has non-small cell lung cancer (NSCLC) with a predominant squamous cell histology. * Subject is receiving therapeutic anticoagulation therapy. * Subject has a history of/or currently exhibits clinically significant events of bleeding (e.g., hemoptysis). * Subject has proteinuria Common Terminology Criteria (CTC) Grade \> 2 at baseline. * Subject currently exhibits symptomatic or persistent, uncontrolled hypertension. * Subject has a history of myocardial infarction within 6 months. * Subject has known autoimmune disease with renal involvement. * Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV). * Clinically significant uncontrolled conditions/medical symptoms. * Subject has a documented left ventricular (LV) ejection fraction \< 50%. * Subject has previously received linifanib.
References
Publications (0)
Data not yet available
No reference posted for this study.