Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

NCT ID: NCT05693090

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2027-07-27

Brief Summary

This is a Phase 1a/b, multicenter, open-label, dose escalation (1a) and dose expansion (1b) study. The purpose of this study is to measure safety, tolerability, and preliminary efficacy with the combination of tipifarnib with osimertinib in patients with advanced/metastatic EGFR-mutated non-small cell lung cancer.

Conditions

NSCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escalation Cohort

Adult participants with EGFR-mutated Non-Small Cell Lung Cancer

Group Type: EXPERIMENTAL

Tipifarnib

Intervention Type: DRUG

Oral administration

Osimertinib

Intervention Type: DRUG

Oral administration

Expansion Cohort

Adult participants with EGFR-mutated Non-Small Cell Lung Cancer

Group Type: EXPERIMENTAL

Tipifarnib

Intervention Type: DRUG

Oral administration

Osimertinib

Intervention Type: DRUG

Oral administration

Interventions

Tipifarnib

Oral administration

Intervention Type: DRUG

Osimertinib

Oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years at the time of signing informed consent.
• Histologically or cytologically confirmed stage IIIB (locally-advanced) or IV (metastatic) adenocarcinoma of the lung.
• The tumor harbors an Ex19del or Ex21-L858R substitution (based on tumor tissue or plasma [ctDNA] assessment).
• Treatment-naïve for locally advanced/metastatic EGFR-mutated NSCLC and osimertinib treatment-naïve for NSCLC.
• ECOG performance score of 0 or 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• Measurable disease by RECIST v1.1 that meets the criteria for selection as a target lesion according to RECIST v1.1.
• Adequate organ function, as evidenced by the laboratory results.

Exclusion Criteria

• Treatment with any of the following:

1. Major surgery

2. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug

3. Medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 or uridine 5'-diphospho (UDP)-glucuronosyltransferase (UGT), or inhibitors of breast cancer resistance protein (BCRP).

4. Investigational therapy within 2 weeks of Cycle 1 Day 1

5. Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration-sensitive prostate cancer)

• Spinal cord compression or symptomatic and unstable brain metastases requiring steroids over the last 4 weeks prior.
• Evidence of severe or uncontrolled systemic diseases.
• Refractory nausea and vomiting, chronic gastrointestinal (GI) diseases, inability to swallow the formulated product, or previous significant bowel resection.
• Clinically significant cardiovascular symptoms or disease.
• Received treatment for unstable angina within prior year, myocardial infarction within the prior 6 months, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kura Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Providence Medical Group

Santa Rosa, California, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Countries

United States

Other Identifiers

KO-TIP-015

Identifier Type: -

Identifier Source: org_study_id