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A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
OP-1250
Palbociclib
Sponsored by
Olema Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Site 6104
  • Site 6102Recruiting
  • Site 6101Recruiting
  • Site 6103Recruiting
  • Site 6105Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation

Dose Expansion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Dose Limiting Toxicities
Characterization and Incidence in Adverse Events and Serious Adverse Events
Plasma levels of OP-1250 and Palbociclib

Secondary Outcome Measures

Full Information

First Posted
February 11, 2022
Last Updated
February 23, 2022
Sponsor
Olema Pharmaceuticals, Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05266105
Brief Title
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olema Pharmaceuticals, Inc.
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Expansion
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
OP-1250
Intervention Description
Complete Estrogen Receptor Antagonist
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
Ibrance®️
Intervention Description
Palbociclib is an approved CDK 4/6 Inhibitor drug
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities
Time Frame
From Cycle 1 Day 1 through C1 Day 28
Title
Characterization and Incidence in Adverse Events and Serious Adverse Events
Time Frame
From initial inform consent date through 30 days post last dose
Title
Plasma levels of OP-1250 and Palbociclib
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
General Contact Info
Phone
415-651-7206
Email
clinical@olema.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Johnson
Organizational Affiliation
Olema Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site 6104
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Site 6102
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site 6101
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site 6103
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Site 6105
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

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