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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04505826




Registration number
NCT04505826
Ethics application status
Date submitted
21/07/2020
Date registered
10/08/2020
Date last updated
22/08/2023

Titles & IDs
Public title
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Scientific title
A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer
Secondary ID [1] 0 0
OP-1250-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone Receptor Positive Breast Carcinoma 0 0
HER2-negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OP-1250

Experimental: OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion) - Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.

Experimental: OP-1250 Phase II - This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts.
Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.


Treatment: Drugs: OP-1250
Complete Estrogen Receptor ANtagonist (CERAN)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
The first 28 days of treatment
Primary outcome [2] 0 0
Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250
Timepoint [2] 0 0
Up to 42 days after end of treatment
Primary outcome [3] 0 0
Pharmacokinetics of OP-1250
Timepoint [3] 0 0
Every 28 days
Primary outcome [4] 0 0
Anti-tumor activity of OP-1250
Timepoint [4] 0 0
Every 8 weeks

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Must have received at least 1 prior hormonal regimen and at least 6 months of a prior
continuous endocrine therapy for locally advanced or metastatic disease

- Must not have received prior oral endocrine therapy < 2 weeks prior to first dose

- Must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever
is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks
or 5 half-lives whichever is earlier, prior to the first dose

- Adequate hepatic function

- Adequate renal function

- Normal coagulation panel

- Willingness to use effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Gastrointestinal disease

- Significant renal disease

- Significant cardiovascular disease

- Significant ECG abnormalities

- Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial
therapy)

- Pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment hospital [2] 0 0
Westmead - Westmead
Recruitment hospital [3] 0 0
ICON Cancer Centre - Auchenflower
Recruitment hospital [4] 0 0
Cancer Research South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Olema Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy
open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced
and/or metastatic hormone receptor (HR)-positive, her2-negative breast cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04505826
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Shilkrut, MD
Address 0 0
Olema Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04505826