Trials / Completed
CompletedNCT03439462
Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer
A Phase 1/2 Multi-center Investigation of ABI-009 (Nab-rapamycin) in Combination With FOLFOX and Bevacizumab as First-line Therapy in Patients With Advanced or Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Aadi Bioscience, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
A phase 1/2 multi-center investigation of nab-sirolimus (also known as ABI-009, nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients with metastatic colorectal cancer
Detailed description
This study is a prospective phase 1/2, single arm, open-label, multi-institutional study to identify the RP2D and determine the efficacy and safety profile of nab-sirolimus administered as first-line therapy in combination with mFOLFOX6 and bevacizumab in patients with metastatic colorectal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-sirolimus | nab-sirolimus combined with mFOLFOX6 + bevacizumab |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2022-08-16
- Completion
- 2022-08-26
- First posted
- 2018-02-20
- Last updated
- 2024-01-02
- Results posted
- 2024-01-02
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03439462. Inclusion in this directory is not an endorsement.