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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/NCT05266105




Registration number
NCT05266105
Ethics application status
Date submitted
11/02/2022
Date registered
4/03/2022
Date last updated
6/06/2024

Titles & IDs
Public title
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Scientific title
A Phase 1 Dose Escalation and Expansion Open-label, Multicenter, Study of OP-1250 in Combination With the CDK4/6 Inhibitor Palbociclib in Adult Subjects With Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
Secondary ID [1] 0 0
OP-1250-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Palazestrant
Treatment: Drugs - Palbociclib

Experimental: Dose Escalation - This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer

Experimental: Dose Expansion - This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy


Treatment: Drugs: Palazestrant
Complete Estrogen Receptor Antagonist

Treatment: Drugs: Palbociclib
Palbociclib is an approved CDK 4/6 Inhibitor drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities
Timepoint [1] 0 0
From Cycle 1 Day 1 through C1 Day 28
Primary outcome [2] 0 0
Characterization and Incidence in Adverse Events and Serious Adverse Events
Timepoint [2] 0 0
From initial inform consent date through 30 days post last dose
Primary outcome [3] 0 0
Plasma levels of OP-1250 and Palbociclib
Timepoint [3] 0 0
Up to 9 months

Eligibility
Key inclusion criteria
- Confirmed and evaluable locally advanced or metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Must not have received prior oral endocrine or targeted therapy = 2 weeks prior to
first dose

- Must not have received prior chemotherapy, antibody therapy, or investigational
therapy = 4 weeks prior to the first dose

- Prior radiotherapy must have been completed 2 weeks prior to first dose

- Adequate safety laboratory tests

- 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 hepatic disease

- Significant cardiovascular disease

- Significant ECG abnormalities

- History of pulmonary embolism or high risk of thrombosis

- Known HIV infection

- Active infection (requiring antimicrobial therapy)

- Pregnant

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
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
10/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Site 6108 - Waratah
Recruitment hospital [2] 0 0
Site 6104 - Westmead
Recruitment hospital [3] 0 0
Site 6102 - South Brisbane
Recruitment hospital [4] 0 0
Site 6109 - Southport
Recruitment hospital [5] 0 0
Site 6101 - Clayton
Recruitment hospital [6] 0 0
Site 6106 - Frankston
Recruitment hospital [7] 0 0
Site 6103 - Geelong
Recruitment hospital [8] 0 0
Site 6105 - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Olema Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum
tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®?, Pfizer Inc.).
Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the
preliminary anti-tumor activity of the combination in adult subjects with hormone
receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05266105
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sue Johnson
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