Clinical Trials in the UK / NCT04288089
Active, not recruiting
Phase 1
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
NCT04288089 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Receptors, EstrogenGenes, Erbb-2Breast Neoplasms
Investigational drug(s) / intervention(s)
Palbociclib (75, 100, 125 milligram [mg])H3B-6545 (150, 300, 450 mg)
Palbociclib (75, 100, 125 milligram [mg]): Palbociclib orally, once daily (QD).
H3B-6545 (150, 300, 450 mg): H3B-6545 orally, QD.
Study summary
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Eligibility
Inclusion Criteria:
1. ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory
2. Prior therapy in the advanced/metastatic setting
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Has adequate bone marrow and organ function
Exclusion Criteria:
1. Uncontrolled significant active infections
2. Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug
3. Inability to take oral medication or presence of malabsorption
4. Active cardiac disease or a history of cardiac dysfunction
5. Evidence of ongoing Alcohol or Drug Abuse
Primary outcome measure(s)
- Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib — Cycle 1 (Cycle length = 28 Days)
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose-Limiting Toxicity (DLT) in the dose cohort. DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with the study drug could not be ruled out: febrile neutropenia; Grade 4 neutropenia that was not resolved within 7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia lasting greater than (\>) 7 days or associated with clinically significant bleeding; Grade 4 vomiting and diarrhea; Grade 3 vomiting and diarrhea lasting \> 72 hours despite treatment; Grade 4 electrolyte abnormality or Grade 3 abnormality lasting \> 24 hours; Grade 3 or 4 serum creatinine or bilirubin increase; Grade 4 biochemistry or Grade 3 lasting \> 7 days; Grade 4 or Grade 3 or intolerable grade 2 toxicities of any non-hematologic adverse event.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Cancer Specialists South - SCRI - PPDS | Sarasota | Florida | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Saint Luke's Cancer Institute | Kansas City | Missouri | |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | |
| Tennessee Oncology, PLLC - SCRI - PPDS | Nashville | Tennessee | |
| Royal Marsden NHS Foundation Trust | London | United Kingdom | |
| Sarah Cannon Research Institute UK - SCRI | London | United Kingdom | |
| Royal Marsden NHS Foundation Trust | Sutton | United Kingdom |
More Eisai Inc. trials in the UK
Study of E7386 in Participants With Selected Advanced Neoplasms
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04288089 on ClinicalTrials.gov ↗ ← All trials in the UK