Study of BCD-115 in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer

NCT03065010 | Completed Phase 1

• 1 other identifier: BCD-115-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration versus time curve (AUC0-t)

  To determine AUC0-t after single doses of BCD-115 p.o. administration with dose escalation;

  90 days

• Peak Plasma Concentration (Cmax)

  To determine observed maximum concentration in plasma or serums after single doses of BCD-115 p.o. administration with dose

  90 days

• The incidence and severity of AEs

  The incidence and severity of AEs (%) related with the therapy based on results of review by 3 experts (%)

  90 days

• The incidence of grade 3-4 AEs

  The incidence of grade 3-4 AEs (%) related with the therapy based on results of review by 3 experts

  90 days

Secondary Outcomes (1)

• Treatment discontinuation due to adverse events

  90 days

Study Arms (1)

BCD-115 in dose escalation regimen

OTHER

BCD-115 will be 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.

Drug: BCD-115

Interventions

BCD-115 DRUG

Inhibitor of CDK8/19

BCD-115 in dose escalation regimen

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Femaile gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and ability to follow the Protocol procedures;
• Age ≥18 years;
• Female gender;
• Postmenopausal status (Prior bilateral surgical oophorectomy; or medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause);
• Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease;
• Progression of advanced breast cancer on first line endocrine therapy for advanced breast cancer.
• ER positive tumor ≥ 10%;
• HER2 negative breast cancer by FISH or IHC;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• Measurable disease according to RECIST 1.1 (only bone disease is not allowed)
• Resolution of all acute toxic effects of prior therapy (including endocrine therapy) or surgical procedures to CTCAE grade ≤1
• Adequate organ function;
• Life expectancy - 12 weeks or more from the moment of randomization

You may not qualify if:

• HER2-positive tumour ;
• Patients with unstable brain metastases, advanced, symptomatic, visceral spread disease, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement).
• Important cardiovascular events in the past 6 months to randomization;
• GI diseases which may affect the absorption of the study drug;
• Inadequate hematopoietic function: neutrophils ≤1500/mm3, platelets ≤100 000/mm3,or hemoglobin ≤90 g/L;
• Inadequate renal function: creatinine level ≥ 1.5 × upper limit of normal (ULN);
• Inadequate liver function: bilirubin level ≥ 1.5 × ULN, AST and ALT levels ≥ 2.5 × ULN (5 × ULN for patients with liver metastases), alkaline phosphatase level ≥ 5 × ULN;
• Concurrent antitumor treatment 21 days before randomization (surgery, radiation therapy; chemotherapy, except endocrine therapy);
• Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;
• Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);
• Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;
• Acute or active chronic infections;
• HCV, HBV, HIV or syphilis infections;
• Obstacles to p.o. administration of study drug.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

N.N. Blokhin Russian Cancer Research Center

Saint Petersburg, 196153, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 27, 2017
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

RU (1)