A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

NCT01174563 | Completed Phase 2 Results

• 1 other identifier: ML25200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 16

Brief Summary

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) According to Grade of Rash

  PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

  Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Secondary Outcomes (2)

• Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4

  Day 1 of treatment period until disease progression or death (approximately up to 67 months)

• Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4

  Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva] DRUG

150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants, \>/= 18 years of age
• Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC)
• Presence of epidermal growth factor receptor (EGFR) mutations
• Previously untreated with any systemic anti-neoplastic therapy for advanced disease
• Last dose of a prior systemic anti-neoplastic therapy for early-stage disease \>/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy
• A life expectancy of at least 12 weeks
• Able to comply with the study and its follow-up procedures
• Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms)

You may not qualify if:

• Pregnant or breast feeding women
• Granulocyte count \<1.5 x 109/L and platelet count \<100\*10\^9/L
• Serum bilirubin \>1.5 upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 \* ULN (or \>5 \* ULN if clearly attributable to liver metastasis)
• Serum creatinine \>1.5 ULN or creatinine clearance \<60 mL/min
• Known allergy or other adverse reaction to study drug or any other related compound
• Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease)
• Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
• Newly diagnosed or not yet definitively treated (i.e. stable disease \>/= 2 months) CNS metastases or spinal cord compression
• Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study)
• Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease
• Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Clalit Health Services: collaborator

Study Sites (16)

Haemek Hospital; Oncology

Afula, 18101, Israel

Location

Barzilai; Oncology

Ashkelon, 78278, Israel

Location

Soroka Medical Center; Oncology Dept

Beersheba, 8410101, Israel

Location

Carmel Hospital; Oncology Unit

Haifa, 34362, Israel

Location

Rambam Medical Center; Oncology

Haifa, 3525408, Israel

Location

Wolfson Hospital; Oncology

Holon, 58100, Israel

Location

Shaare Zedek Medical Center; Oncology Dept

Jerusalem, 91031, Israel

Location

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112001, Israel

Location

Meir Medical Center; Oncology

Kfar Saba, 4428164, Israel

Location

Nahariya Hospital; Oncology

Nahariya, 22100, Israel

Location

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, 5262100, Israel

Location

Kaplan Medical Center; Oncology Inst.

Rehovot, 7610001, Israel

Location

Ziv Medical Center; Oncology Department

Sefad, 13100, Israel

Location

Sourasky / Ichilov Hospital; Oncology Department

Tel Aviv, 64239-06, Israel

Location

Poria Hospital; Oncology

Tiberias, 15208, Israel

Location

Assaf Harofeh; Oncology

Ẕerifin, 6093000, Israel

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 3, 2010
• Study Start: May 23, 2011
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: September 17, 2018
• Results First Posted: September 17, 2018

Record last verified: 2018-09

Locations

IL (16)