Tarceva and AT-101 for Patients With Advanced Non-Small Cell Lung Cancer

NCT00934076 | Withdrawn Phase 1 DMC

• 2 other identifiers: F090218006UAB 0831
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study the safety and effectiveness of oral AT-101 when given with the standard dose of erlotinib (Tarceva)to patients who are older that 18 and who have advanced non-small cell lung cancer, who have relapsed or progressed on prior platinum-based chemotherapy. It is proposed that the effects of AT-101 may improve the clinical benefit of erlotinib in patients with advanced NSCLC.

Conditions

Carcinoma, Non Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of erlotinib plus AT-101

  Assessment of toxicity will be performed on day 15 of the first cycle, and then on day 1 of every cycle of treatment.

Secondary Outcomes (1)

• Evaluation of efficacy for erlotinib plus AT-101 using the binary outcome "alive without progression at 6 months (AWOP6)" as a secondary endpoint.

  6 months

Study Arms (1)

AT-101 plus Erlotinib

EXPERIMENTAL

Subjects will begin study treatment at 150 mg of erlotinib taken once daily in a continuous regimen expressed in 3 week cycles. Subjects will begin treatment with oral AT-101 at 40 mg twice daily for 3 days of each 3 week cycle on an outpatient basis.

Drug: Tarceva plus AT-101

Interventions

Tarceva plus AT-101 DRUG

150 mg of Tarceva taken once daily in a continuous regimen expressed in 3 week cycles. Oral AT-101 at 40 mg twice daily for 3 days of each 3 week cycle on an outpatient basis.

AT-101 plus Erlotinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological proven diagnosis of NSCLC with positive EGFR status by immunohistochemistry. Patients will be considered as positive if greater than 10% of the tumor cells are positively stained by the EGFR pharmDX assay kit.
• Disease that is locally advanced, metastatic, or recurrent.
• Prior treatment with 1 or 2 chemotherapy regimens, including a platinum based regimen for advanced disease (stage IIIB with malignant pleural effusion or stage IV).
• Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors \[RECIST\].
• Radiographic evidence of disease progression during or following previous chemotherapy treatment.
• Formalin fixed, paraffin embedded tumor tissue from the initial diagnoses will be obtained.
• Male or female, 19 years of age or older.
• ECOG performance status 0 2.
• Resolution of all acute toxic effects of prior therapy or surgical procedures (except for alopecia).
• Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of therapy. Prophylactic use of bisphosphonates in patients without bone disease, except for the treatment of osteoporosis, is not permitted.
• Ability to swallow and retain oral medication.
• Adequate organ function as defined by the following criteria:
• Hemoglobin \>9.0 g/dL.
• Absolute neutrophil count (ANC) \>1500/μL.
• Platelet \>100,000/μL.

You may not qualify if:

• Prior treatment with \>2 systemic chemotherapy based regimens for advanced disease (stages IIIB/IV).
• Prior treatment with any EGFR inhibitors (TK inhibitor or monoclonal antibody).
• Symptomatic brain metastases or spinal cord compression; subjects will be eligible after adequate treatment (radiotherapy, surgery) and having stable disease not requiring steroids.
• Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated.
• Any significant acute or chronic medical (e.g., gastrointestinal complications, myocardial infarction, unstable angina, congestive heart failure, cerebrovascular accident, infection, metabolic complications, etc.) or psychiatric conditions that would impart, in the judgment of the investigator, excess risk associated with study participation, or study drug administration.
• Known human immunodeficiency virus (HIV) infection.
• Current treatment on other therapeutic clinical trials.
• Known hypersensitivity to gossypol, its enantiomers, or its excipients.
• Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
• Patients with symptomatic hypercalcemia or hypercalcemia that is \> grade 2.
• Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
• Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test within 3 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Ascenta Therapeutics: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; gossypol acetic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Francisco Robert, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2011-01