Trials / Completed
CompletedNCT03065010
Study of BCD-115 in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer
A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and Pharmacokinetics of BCD-115 (JSC BIOCAD, Russia) in Combination With Endocrine Therapy in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Biocad · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and Pharmacokinetics of Oral BCD-115 (JSC BIOCAD, Russia) in Combination with Endocrine Therapy in Women with ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer
Detailed description
Multicentre dose-finding open-label non-comparative phase Ia/Ib clinical trial for investigation of the safety, tolerability, pharmacokinetics of BCD-115 administered p.o. with intrapatient dose escalation in the population of patients with ER(+) HER2(-) advanced breast cancer in combination with a standard dose of endocrine therapy. The trial will be conducted in two stages: Stage 1 - finding of the maximum tolerated dose, determination of the recommended dose for Stage 2. Stage 2 - study of the recommended dose from Stage 1 of BCD-115, analysis of tolerability and safety of selected dose/doses in additional cohorts, and determination of the estimated therapeutic dose/doses for further clinical studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCD-115 | Inhibitor of CDK8/19 |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2017-02-27
- Last updated
- 2018-03-13
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03065010. Inclusion in this directory is not an endorsement.