Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
OP-1250-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of Dose Limiting Toxicities
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From Cycle 1 Day 1 through C1 Day 28
Query!
Primary outcome [2]
0
0
Characterization and Incidence in Adverse Events and Serious Adverse Events
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
From initial inform consent date through 30 days post last dose
Query!
Primary outcome [3]
0
0
Plasma levels of OP-1250 and Palbociclib
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to 9 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/12/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Site 6108 - Waratah
Query!
Recruitment hospital [2]
0
0
Site 6104 - Westmead
Query!
Recruitment hospital [3]
0
0
Site 6102 - South Brisbane
Query!
Recruitment hospital [4]
0
0
Site 6109 - Southport
Query!
Recruitment hospital [5]
0
0
Site 6101 - Clayton
Query!
Recruitment hospital [6]
0
0
Site 6106 - Frankston
Query!
Recruitment hospital [7]
0
0
Site 6103 - Geelong
Query!
Recruitment hospital [8]
0
0
Site 6105 - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [4]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [5]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [6]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [7]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Olema Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Pfizer
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05266105
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sue Johnson
Query!
Address
0
0
Olema Pharmaceuticals, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05266105
Download to PDF