A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

  • STATUS
    Recruiting
  • End date
    Jul 26, 2024
  • participants needed
    170
  • sponsor
    Bayer
Updated on 26 March 2021
cancer
kidney function tests
experimental drug
primary tumor
brain metastases
solid tumor
NTRK
renal function tests
fibrosarcoma
kidney function test

Summary

This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.

Description

The trial will be conducted in 2 parts: dose escalation and expansion (Phase 1) and Phase 2.

The primary objective of Phase 1 is to establish the recommended dose of selitrectinib to treat neurotrophic tyrosine kinase (NTRK) fusion cancers in patients a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase 1 are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.

The primary objective of Phase 2 is to assess the overall response rate in NTRK fusion cancer patients as determined by an independent radiology committee (IRR). Secondary objectives of Phase 2 comprise the safety and efficacy of selitrectinib at the recommended dose.

Details
Condition Pancreatic Cancer, Fibrosarcoma, Bronchogenic Carcinoma, Non-Small Cell Lung Cancer, Bile duct carcinoma, Intestinal Cancer, Colorectal Cancer, Mesoblastic Nephroma, Cholangiocarcinoma, Astrocytoma, Invasive Ductal Breast Carcinoma, Thyroid Adenoma, Uterine Cancer, Central Nervous System Neoplasms, Respiratory Tract Neoplasm, Thoracic Neoplasms, Biliary neoplasm, Ovarian Cancer, Nerve Sheath Tumors, Glioblastoma Multiforme, Nevi and Melanomas, melanoma, Renal Cell Carcinoma, gliomas pontine, Lung Neoplasm, skin cancer, Malignant neoplasm of brain, Sarcoma, Bronchial Neoplasm, gastrointestinal stromal tumor, salivary gland cancer, Neoplasms, Nerve Tissue, Metastatic Melanoma, Colon Cancer Screening, Brain Tumor (Pediatric), Colon cancer; rectal cancer, Head and Neck Squamous Cell Carcinoma, Skin Carcinoma, Recurrent Ovarian Cancer, Urothelial Tract Cancer, Sarcoma (Pediatric), Islet Ce417ll Cancer, Infantile Fibrosarcoma, Breast Secretory Carcinoma, Lung Cancer, Brain Cancer, Malignant Melanoma, Biliary Tract Cancer, Brain Tumor, Thyroid Cancer, Renal Cell Cancer, Soft Tissue Sarcoma, Solid Tumors Harboring NTRK Fusion
Treatment LOXO-195, BAY2731954, Selitrectinib (BAY2731954)
Clinical Study IdentifierNCT03215511
SponsorBayer
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 1 yrs?
Gender: Male or Female
Do you have any of these conditions: Bronchial Neoplasm or Intestinal Cancer or Pancreatic Cancer or Metastatic Melanoma or Bile duct carcinoma or Ovarian Cancer or Invasive Ductal Breast...?
Do you have any of these conditions: Malignant neoplasm of brain or Solid Tumors Harboring NTRK Fusion or gliomas pontine or Sarcoma (Pediatric) or Bile duct carcinoma or Astrocytoma or B...?
Do you have any of these conditions: gliomas pontine or Thyroid Cancer or Skin Carcinoma or Ovarian Cancer or skin cancer or salivary gland cancer or Colon cancer; rectal cancer or Invasi...?
Do you have any of these conditions: Soft Tissue Sarcoma or Bronchial Neoplasm or Lung Neoplasm or Recurrent Ovarian Cancer or Solid Tumors Harboring NTRK Fusion or Infantile Fibrosarcoma...?
Do you have any of these conditions: Cholangiocarcinoma or gliomas pontine or Thyroid Cancer or Bronchial Neoplasm or Uterine Cancer or Astrocytoma or Sarcoma (Pediatric) or Bronchogenic ...?
Do you have any of these conditions: Ovarian Cancer or melanoma or Malignant neoplasm of brain or Metastatic Melanoma or skin cancer or Biliary neoplasm or Renal Cell Carcinoma or Lung Ne...?
Do you have any of these conditions: melanoma or Neoplasms, Nerve Tissue or Malignant neoplasm of brain or Non-Small Cell Lung Cancer or salivary gland cancer or Astrocytoma or gliomas po...?
Do you have any of these conditions: Solid Tumors Harboring NTRK Fusion or Lung Neoplasm or Renal Cell Carcinoma or Bronchial Neoplasm or Nerve Sheath Tumors or gastrointestinal stromal t...?
Do you have any of these conditions: salivary gland cancer or Colon cancer; rectal cancer or melanoma or Renal Cell Carcinoma or Biliary Tract Cancer or Skin Carcinoma or Uterine Cancer o...?
Do you have any of these conditions: Renal Cell Cancer or Nerve Sheath Tumors or Infantile Fibrosarcoma or Colon Cancer Screening or Soft Tissue Sarcoma or Renal Cell Carcinoma or Brain T...?
Do you have any of these conditions: Urothelial Tract Cancer or Thyroid Cancer or Lung Cancer or Bronchogenic Carcinoma or Sarcoma (Pediatric) or Recurrent Ovarian Cancer or Central Nervo...?
Do you have any of these conditions: Nevi and Melanomas or Thoracic Neoplasms or Glioblastoma Multiforme or Biliary neoplasm or Invasive Ductal Breast Carcinoma or Uterine Cancer or Lung ...?
Advanced solid tumor for which, in the opinion of the investigator, no other standard therapy offers greater benefit
A solid tumor diagnosis in the setting of
a) a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
b) a documented NTRK fusion unresponsive to a prior TRK inhibitor
c) a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
NTRK gene fusions will be identified in a CLIA-certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented. Patients with infantile fibrosarcoma (IFS) or congenital mesoblastic nephroma (CMN) may be enrolled based on an ETV6+ FISH test without identifying NTRK3
Performance Status: Eastern Cooperative Oncology Group (ECOG) score 2 in adults or Karnofsky Performance Score (KPS) Score50% (age 16 years) or Lansky Performance Score (LPS) 40% (age < 16 years)
Life expectancy of at least 3 months
Adequate hematologic, hepatic and renal function
Patients with stable central nervous system (CNS) primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of selitrectinib
Ability to receive study drug orally or by enteral administration

Exclusion Criteria

Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX-0005)), taletrectinib (DS-6501b/AB-106)). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed
Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville oranges, or drugs associated with QT prolongation
Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of selitrectinib, or prolongation of QT interval corrected for heart rate (QTc interval) >480 milliseconds within past 6 months
Major surgery within 7 days of enrollment
Uncontrolled systemic bacterial, fungal or viral infection
Pregnancy or lactation
Known hypersensitivity to selitrectinib or Ora-Sweet SF and OraPlus for patients receiving liquid formulation
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