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JOURNAL ONKOLOGIE – STUDIE
PIKASSO-01

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

Rekrutierend

NCT-Nummer:
NCT05307705

Studienbeginn:
Mai 2022

Letztes Update:
20.03.2024

Wirkstoff:
LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole, Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Eli Lilly and Company

Collaborator:
Loxo Oncology, Inc.

Studienleiter

Vincent Chau, MD; PhD
Study Director
Loxo Oncology, Inc.

Kontakt

Studienlocations
(3 von 55)

Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
3000 Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia IRCCS
20141 Milano
ItalyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

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

Studien-Rationale

Primary outcome:

1. 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) (Time Frame - During the first 28-day cycle of LOXO-783 treatment):
Number of patients with DLTs

2. Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities (Time Frame - During the first 28-day cycle of LOXO-783 treatment):
Number of patients with DLT-equivalent toxicities

Secondary outcome:

1. To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC) (Time Frame - Up to 2 months):
PK of LOXO-783: AUC

2. To assess the PK of LOXO-783: Maximum drug concentration (Cmax) (Time Frame - Up to 2 months):
PK of LOXO-783: Cmax

3. To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR) (Time Frame - Up to approximately 36 months or 3 years):
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

4. To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR) (Time Frame - Up to approximately 36 months or 3 years):
BOR per investigator assessed RECIST 1.1

5. To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR) (Time Frame - Up to approximately 36 months or 3 years):
DOR per investigator assessed RECIST 1.1

6. To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR) (Time Frame - Up to approximately 36 months or 3 years):
DCR per investigator assessed RECIST 1.1

7. To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR) (Time Frame - Up to approximately 36 months or 3 years):
CBR per investigator assessed RECIST 1.1

8. To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR) (Time Frame - Up to approximately 36 months or 3 years):
TTR per investigator assessed RECIST 1.1

9. To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS) (Time Frame - Up to approximately 36 months or 3 years):
PFS per investigator assessed RECIST 1.1

10. To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS) (Time Frame - Up to approximately 36 months or 3 years):
OS per investigator assessed RECIST 1.1

Studien-Arme

  • 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

Geprüfte Regime

  • LOXO-783 (LY3849524):
    Oral
  • Fulvestrant:
    Intramuscular
  • Imlunestrant (LY3484356):
    Oral
  • Abemaciclib (LY2835219):
    Oral
  • Anastrozole, Exemestane, or Letrozole:
    Oral
  • Paclitaxel:
    Intravenous

Quelle: ClinicalTrials.gov


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