Alectinib-induced Endocrine Toxicity

NCT06339554 | Completed FDA Drug

• 1 other identifier: 4806
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated for full hormone assessment of androgen deficiency, AT 8 weeks after treatment start and in case of reported suspected symptoms. Patients with major sexual dysfunctions were referred to endocrinologist.

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (2)

• Incidence of endocrine toxicity in overall ALK-positive

  Percentege of endocrine alterations among patients included in Cohort A and B

  Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Incidence of symptomatic hypogonadism in male ANSCLC patients

  Percentage of endocrine alterations and/or clinical sexual dysfuctions among male patients included in Cohort A and C

  Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Study Arms (3)

Cohort A

Male ALK-positive ANSCLC patients receiving first-line treatment with alectinib

Drug: Alectinib 150 MG [Alecensa]

Cohort B

Female ALK-positive ANSCLC patients receiving first-line treatment with alectinib

Drug: Alectinib 150 MG [Alecensa]

Cohort C

Male ALK-negative ANSCLC patients receiving first-line treatment according to molecular profiling

Interventions

Alectinib 150 MG [Alecensa] DRUG

First line treatment for cohorts A and B

Also known as: Alecensa

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Cohort A + C = male Cohort B = female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TOSS-ALK is single-Institution observational prospective sex-based trial aimed to assess endocrine toxicity in ALK+ advanced/metastatic ANSCLC male patients treated with first-line alectinib (Cohort A). As control cohorts, we included female ALK+ ANSCLC patients (Cohort B) and male patients with NON-ALK+ NSCLC who are receiving active treatment (ACT) according to tumour molecular profiling (Cohort C).

You may qualify if:

• Histologically or cytologically confirmed advanced NSCLC (ANSCLC) For ALK+ NSCLC (Cohorts A-B) 1a. ALK-rearrangement confirmed by NGS and/or VENTANA ALK (D5F3) immunoistochemical assay 1b. Treatment naïve patients candidate to treatment with alectinib oral at standard dose of 600 mg twice daily
• Patient aged 18 to 70 years
• To be sexually active at time of enrolment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Written informed consent

You may not qualify if:

• History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years
• Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:
• a. Cancer-related conditions that may preclude/undermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications)
• b. History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)
• c. Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)
• d. Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics
• e. Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
• f. Major psychological disorder and/or high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: October 12, 2018
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

IT (1)