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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05307705




Registration number
NCT05307705
Ethics application status
Date submitted
25/03/2022
Date registered
1/04/2022
Date last updated
26/10/2024

Titles & IDs
Public title
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Scientific title
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Secondary ID [1] 0 0
J4C-OX-JZUA
Secondary ID [2] 0 0
LOXO-PIK-21001
Universal Trial Number (UTN)
Trial acronym
PIKASSO-01
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 - LOXO-783
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Anastrozole, Exemestane, or Letrozole
Treatment: Drugs - Paclitaxel

Experimental: Phase 1A: LOXO-783 Monotherapy Dose Escalation - LOXO-783 administered orally

Experimental: Phase 1B: Part A - LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally

Experimental: Phase 1B: Part B - LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally

Experimental: Phase 1B: Part C - LOXO-783 orally in combination with fulvestrant intramuscularly

Experimental: Phase 1B: Part D - LOXO-783 orally in combination with paclitaxel intravenously

Experimental: Phase 1B: Part E - LOXO-783 orally

Experimental: Phase 1B: Part F - Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly


Treatment: Drugs: LOXO-783
Oral

Treatment: Drugs: Fulvestrant
Intramuscular

Treatment: Drugs: Imlunestrant
Oral

Treatment: Drugs: Abemaciclib
Oral

Treatment: Drugs: Anastrozole, Exemestane, or Letrozole
Oral

Treatment: Drugs: Paclitaxel
Intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
During the first 28-day cycle of LOXO-783 treatment
Primary outcome [2] 0 0
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities
Timepoint [2] 0 0
During the first 28-day cycle of LOXO-783 treatment
Secondary outcome [1] 0 0
To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)
Timepoint [1] 0 0
Up to 2 months
Secondary outcome [2] 0 0
To assess the PK of LOXO-783: Maximum drug concentration (Cmax)
Timepoint [2] 0 0
Up to 2 months
Secondary outcome [3] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)
Timepoint [3] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [4] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)
Timepoint [4] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [5] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)
Timepoint [5] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [6] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)
Timepoint [6] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [7] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)
Timepoint [7] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [8] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)
Timepoint [8] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [9] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)
Timepoint [9] 0 0
Up to approximately 36 months or 3 years
Secondary outcome [10] 0 0
To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)
Timepoint [10] 0 0
Up to approximately 36 months or 3 years

Eligibility
Key inclusion criteria
* Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
* Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
* Have stopped all cancer treatment and have recovered from the major side effects
* Have adequate organ function, as measured by blood tests
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Patients must have

* Measurable disease

--- Patients with non-breast tumor types must have at least 1 measurable lesion
* Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
* For patients with an estrogen receptor (ER)+ breast cancer diagnosis:

* If female, must be postmenopausal
* If male, must agree to use hormone suppression
* Phase 1a:

-- Dose escalation and backfill patients:
* Advanced solid tumor
* Patients may have had up to 5 prior regimens for advanced disease
* Phase 1b:

* Part A:

* ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
* Part B:

* ER+/HER2- advanced breast cancer
* Patients may have had up to 2 prior regimens for advanced disease.
* Part C:

* ER+/HER2- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease.

---- Prior CDK4/6 inhibitor therapy required.
* Have a diagnosis of diabetes mellitus Type 2
* Part D:

* Advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease.
* Part E:

* Advanced solid tumor
* Patients may have had up to 3 prior regimens for advanced disease advanced disease
* Part F:

* ER+/HER2- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease

* Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Medical Conditions

* Colorectal cancer
* Endometrial cancers with specific concurrent oncogenic alterations
* A history of known active or suspected

* Diabetes mellitus Type 1 or
* Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
* Serious concomitant systemic disorder
* Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
* Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

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
11/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [2] 0 0
Cancer Research SA - Adelaide SA
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide SA
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
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
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Toronto
Country [14] 0 0
Canada
State/province [14] 0 0
Vancouver
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Changsha
Country [17] 0 0
China
State/province [17] 0 0
Nanchang
Country [18] 0 0
China
State/province [18] 0 0
Shanghai
Country [19] 0 0
France
State/province [19] 0 0
Angers
Country [20] 0 0
France
State/province [20] 0 0
Caen
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Strasbourg
Country [24] 0 0
France
State/province [24] 0 0
Villejuif
Country [25] 0 0
Germany
State/province [25] 0 0
Hessen
Country [26] 0 0
Germany
State/province [26] 0 0
Württemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Erlangen
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Japan
State/province [29] 0 0
Aichi
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Japan
State/province [31] 0 0
Kyoto
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Singapore
State/province [33] 0 0
Singapore
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Greater London
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Trial website
https://clinicaltrials.gov/study/NCT05307705
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
13176154559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05307705