A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
1 other identifier
interventional
200
2 countries
15
Brief Summary
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Mar 2018
Typical duration for phase_1 breast-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2018
CompletedStudy Start
First participant enrolled
March 18, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2023
CompletedJanuary 8, 2024
January 1, 2024
5.6 years
March 14, 2018
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Approximately 2 years
Secondary Outcomes (5)
Maximum observed serum concentration (Cmax)
Cycle 1 (28 days)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Cycle 1 (28 days)
Time of maximum observed concentration (Tmax)
Cycle 1 (28 days)
Objective response rate (ORR)
up to 12 months
Progression free survival (PFS)
up to 12 months
Study Arms (2)
D-0502
EXPERIMENTALD-0502
D-0502 in combination with palbociclib
EXPERIMENTALD-0502 in combination with palbociclib
Interventions
Eligibility Criteria
You may qualify if:
- Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
- Female patients with menopausal status:
- i. Postmenopausal status defined as meeting at least one of the following criteria:
- Have undergone a bilateral oophorectomy any time in life;
- Age ≥60 years, or
- Age \<60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value \>40 milli-international units per milliliter (mIU/mL) and an estradiol value \<40 picograms per milliliter (pg/mL) (140 picomoles per liter \[pmol/L\]).
- ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH agonist during the study.
- Patients meeting all the following criteria:
- Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;
- Limited number of prior chemotherapy, endocrine therapy, and targeted therapy for advanced or metastatic disease
- Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.
- For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.
You may not qualify if:
- Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
- Participants with prior anticancer or investigational drug treatment within the following windows are excluded:
- Any anti-cancer therapy (including endocrine therapy, chemotherapy, targeted therapy, etc.) less than 30 days before first dose of study treatment.
- Any investigational drug therapy less than 28 days or 4 half-lives (whichever is shorter) prior to first dose of study treatment.
- Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Local Institution
Fresno, California, 93720, United States
Local Institution
Aurora, Colorado, 80012, United States
Local Institution
New Haven, Connecticut, 06511, United States
Local Institution
Boston, Massachusetts, 02114, United States
Local Institution
Eugene, Oregon, 97401, United States
Local Institution
Greenville, South Carolina, 29605, United States
Local Institution
Nashville, Tennessee, 37203-1619, United States
Local Institution
Dallas, Texas, 75246, United States
Local Institution
San Antonio, Texas, 78217, United States
Local Institution
San Antonio, Texas, 78229, United States
Local Institution
Tyler, Texas, 75702, United States
Local Institution
Beijing, Chaoyang District, 100021, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Changsha, Hunan Provence, China
Local Institution
Shenyang, Liaoning, 110042, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 20, 2018
Study Start
March 18, 2018
Primary Completion
October 18, 2023
Study Completion
October 18, 2023
Last Updated
January 8, 2024
Record last verified: 2024-01