Trials / Completed
CompletedNCT03810742
Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- PharmaEngine · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers
Detailed description
Primary Objectives * to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) * to evaluate the toxicity profile of the combination therapy Secondary Objectives * to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®) * to study the pharmacokinetics of the combination therapy A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nanoliposomal Irinotecan | Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®) |
Timeline
- Start date
- 2019-03-05
- Primary completion
- 2022-05-04
- Completion
- 2023-10-25
- First posted
- 2019-01-22
- Last updated
- 2023-11-18
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03810742. Inclusion in this directory is not an endorsement.