A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients Wit⦠(NCT04072952) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCEĀ®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
United States217 participantsStarted 2019-08-05
Plain-language summary
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCEĀ®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Part A, Part B, and Part C:
* Patients at least 18 years of age at the time of signing the informed consent.
* Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer for which standard curative therapy is no longer effective or does not exist.
* Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.
* Patients must be willing to undergo a core biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER immunohistochemistry (IHC) testing and pharmacodynamics (PD) studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)
* Women must be postmenopausal due to surgical or natural menopause.
Part A:
\- Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting.
Part B:
* Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting
* Paā¦
What they're measuring
1
Part A: Incidence of Dose Limiting Toxicities of ARV-471
Timeframe: 28 Days
2
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration
3
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration
4
Part B: Assessment of anti-tumor activity of ARV-471
Timeframe: through study completion, up to approximately 2 years
5
Part C: Incidence of Dose Limiting Toxicities of combination ARV-471 + palbociclib
Timeframe: 28 Days
6
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of combination ARV-471 + palbociclib
Timeframe: First study drug dose through a minimum of 30 calendar Days After Last study drug administration
7
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of combination ARV-471 + palbociclib