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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/NCT05307705




Registration number
NCT05307705
Ethics application status
Date submitted
25/03/2022
Date registered
1/04/2022
Date last updated
14/05/2024

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
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
400
Accrual to date
Final
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
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Loxo Oncology, Inc.
Address [1] 0 0
Country [1] 0 0

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/ct2/show/NCT05307705
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vincent Chau, MD; PhD
Address 0 0
Loxo Oncology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Patient Advocacy
Address 0 0
Country 0 0
Phone 0 0
855-569-6305
Fax 0 0
Email 0 0
clinicaltrials@loxooncology.com;
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05307705