Trials / Unknown
UnknownNCT03168061
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
A Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Patients With Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- NanoCarrier Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied.
Detailed description
The first part of the study will determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase 2 (RPII) dose of NC-6300. The second part of the study will assess the activity and tolerability of NC-6300 in patients with soft tissue sarcoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NC 6300 | Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose |
Timeline
- Start date
- 2017-06-30
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2017-05-30
- Last updated
- 2020-02-28
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03168061. Inclusion in this directory is not an endorsement.