Loading clinical trials...

Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

Phase 1 Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy

NCT03201913•TTC Oncology, LLC

View on ClinicalTrials.gov

Summary

Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.

Detailed Description

This is open-label, accelerated dose escalation study of TTC 352, a selective human ER partial agonist for treatment of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy with one that included a CDK4/CDK6 inhibitor. The primary objective of this study is to determine the maximum tolerated dose (MTD) of TTC-352 for the treatment of metastatic ER+ breast cancer progressing after endocrine therapy. The maximum tolerated dose (MTD) of TTC-352 will be determined using initial single-patient cohort escalations until grade 2 toxicity, then expansion to a modified-Fibonacci dose-escalation 3+3 design. Patients enrolled at each dose escalation step must complete the first 28-day cycle of treatment without a dose-limiting toxicity (DLT), or be withdrawn because of a DLT, before additional patients may be enrolled for the next dose escalation step. The MTD dose level cohort will be expanded to a total of 9 patients, to further evaluate safety. In each cohort pharmacokinetics of TTC-352 will be evaluated.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. be ≥18 years of age;
•2. have a diagnosis of metastatic ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy, with one that included a CDK4/CDK6 inhibitor (e.g., palbociclib or ribociclib);
•3. have metastatic disease evaluable on imaging studies;
•4. have a histologically confirmed diagnosis of ER+ breast cancer;
•5. have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (Appendix II);
•6. have adequate hepatic function, defined as having a serum total bilirubin concentration ≤1.5mg/d, or ≤2 x the upper limit of normal (ULN) if associated with hepatobiliary metastases or Gilbert syndrome, and having serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations ≤2.5 × ULN, or ≤5 x ULN for patients with known hepatic metastases;
•7. have adequate renal function, defined as having a serum creatinine ≤1.5 × ULN and a creatinine clearance ≥40mL/min (estimated using the Cockcroft-Gault formula);
•8. have adequate hematologic function, defined as having a hemoglobin ≥8g/dL, an absolute neutrophil count (ANC) ≥1.0 × 109/L, and platelet count ≥75.0 x 109/L;
•9. be willing and able to comply with study visits and procedures;
•10. have read, understood and signed the informed consent form (ICF) approved by the Institutional Review Board (IRB);
+12 more criteria

Exclusion Criteria

•1. have received chemotherapy, hormonal therapy, biologic therapy, immunotherapy or radiation therapy within 14 days prior to the planned start of study treatment.

Locations (4)

HonorHealth Research Institute

Scottsdale, Arizona, United States

HealthPartners Institute, Regions Cancer Care Center

Saint Paul, Minnesota, United States

Sanford Health

Sioux Falls, South Dakota, United States

University of Wisconsin, Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

December 11, 2017

Primary Completion Date

December 31, 2019

Completion Date

April 30, 2020

Last Updated

August 11, 2020

Enrollment

ACTUAL participants

Conditions

Metastatic ER+ Breast Cancer

Interventions

TTC-352

DRUG