Clinical trial · Interventional
AMG 386 Drug-Drug Interaction Study With Paclitaxel
An Open-Label, Pharmacokinetic Drug-Drug Interaction (DDI) Study of AMG 386 in Combination With Paclitaxel in Adult Subjects With Advanced Solid Tumors
NCT01992341CI-TRIAL-00015677completedPhase 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)
The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of paclitaxel
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 |
|---|---|---|---|
| AMG 386 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG 386 15mg/kg and paclitaxel 80mg/m2
- interventionNames
- Drug: AMG 386
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Paclitaxel PK parameters
- timeFrame
- 9 weeks
- description
- Paclitaxel PK parameters with and without the co-administration of AMG 386.
Secondary outcomes (3)
- measure
- AMG 386 PK parameters
- timeFrame
- 9 weeks
- description
- AMG 386 PK steady state PK parameters with and without paclitaxel co-administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women ≥ 18 years of age * Have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Normal or clinically acceptable ECG (12 lead reporting PR, QRS, QTc) Exclusion Criteria: * Subjects with gastric cancer or any malignancy with purely squamous cell histology * Known history of primary central nervous system (CNS) tumors or CNS metastases * Myocardial infarction within 1 year before study day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function * History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study day 1 * A baseline ECG QTc interval \> 450 msec * Active grade 2 or greater peripheral vascular disease * History of pulmonary hemorrhage or gross hemoptysis within 6 months before study day 1 * Non-healing wound, ulcer (including gastrointestinal) or fracture * Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection * Major surgery within 1 month before study day 1 * Concurrent antitumor treatment within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1 * Unable to tolerate IV administration or repeated blood withdrawal * Hypersensitivity to paclitaxel or drugs using the vehicle cremophor * Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing * Chronic neuropathy grade ≥ 1 * Concurrent or prior treatment with 2C8 and 3A4 substrates * Enrolled in or has not yet completed at least 30 days (prior to study day 1) since ending other investigational device or drug, or currently receiving other investigational treatment. * Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386 * Women who are lactating/breastfeeding * Women with a positive pregnancy test * Women planning to become pregnant during the duration of the study
References
Publications (0)
Data not yet available
No reference posted for this study.