Trials / Completed
CompletedNCT03251378
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Hutchison Medipharma Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
Detailed description
The study was an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study consisted of two phases: * A dose escalation phase - Two dose cohorts were evaluated including 3 mg orally QD 3 weeks on/1 week off and 5 mg orally QD 3 weeks on/1 week off. A 3+3 design was used for this portion of the study. * A dose expansion phase - Five cohorts were evaluated in Dose Expansion phase. Cohort A evaluated the MTD/RP2D in patients with advanced solid tumors of any type. Cohort B and Cohort C evaluated the MTD/RP2D in metastatic colorectal cancer patients. Cohort D and Cohort E evaluated the MTD/RP2D in metastatic breast cancer patients. Study was conducted at 9 sites in the United States.
Conditions
- Advanced Solid Tumors
- Metastatic Colon Cancer
- Metastatic Breast Cancer
- Triple Negative Breast Cancer
- HER2-negative Breast Cancer
- Hormone Receptor Positive Breast Carcinoma
- Rectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fruquintinib (HMPL-013) | Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class. |
Timeline
- Start date
- 2017-12-11
- Primary completion
- 2022-12-13
- Completion
- 2023-03-30
- First posted
- 2017-08-16
- Last updated
- 2024-09-25
- Results posted
- 2024-09-25
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03251378. Inclusion in this directory is not an endorsement.