Trials / Completed
CompletedNCT02579811
Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer
A Phase II Study of the Efficacy and Safety of Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer After Treatment With Pd-1 or Pd-L1 Inhibitors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Axitinib is a drug which is approved by the FDA for patients with advanced kidney cancer who have already received some treatment. It works by reducing blood flow to a tumor. Axitinib is normally give at 5mg twice per day and sometimes this dose is increased if patients tolerate it. The purpose of this study is to figure out a different way to decide which dose of axitinib each patient should receive based on the side effects they experience.
Detailed description
Primary objective To determine whether axitinib given on an individualized dose/schedule for metastatic renal cell carcinoma following immunotherapy with PD-1 and PD-L1 Inhibitors leads to improved progression-free survival (PFS). Secondary objectives: 1. To characterize the objective response rates in patients given axitinib on an individualized dose/schedule. 2. To evaluate the tolerability and safety of an alternative method of axitinib titration. 3. To characterize the anti-tumor effect, as measured by change in tumor burden per RECIST 1.1, of axitinib titration performed after initial RECIST PD on axitinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Axitinib | The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria |
Timeline
- Start date
- 2015-12-30
- Primary completion
- 2019-08-21
- Completion
- 2023-06-20
- First posted
- 2015-10-20
- Last updated
- 2023-06-29
- Results posted
- 2020-08-07
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02579811. Inclusion in this directory is not an endorsement.