A RANDOMIZED, PHASE 3 STUDY OF GANETESPIB IN COMBINATION WITH DOCETAXEL VERSUS DOCETAXEL ALONE IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG ADENOCARCINOMA

• Conditions: ADVANCED NON-SMALL-CELL LUNG ADENOCARCINOMA; MedDRA version: 14.1Level: PTClassification code 10025038Term: Lung adenocarcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10025037Term: Lung adenocarcinoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004349-34-ES
• Lead Sponsor: Synta Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Age 18 years or older
2. Histologically confirmed diagnosis of NSCLC, with predominantly adenocarcinoma histology.
3. Stage IIIB/IV NSCLC
4. Only one prior systemic therapy for Stage IIIB/IV disease defined as a platinum-based combination chemotherapy
5. Diagnosis of advanced NSCLC >=6 months prior to signing of informed consent document
6. Documented disease progression during or following first-line therapy for advanced disease
7. Measurable disease
8. Available archived tumor tissue block or at least 10 unstained slides for biomarker testing. If archived tissue is not available, a fresh biopsy will be obtained during the screening period.
9. ECOG PS 0 or 1
10. Adequate hematologic function defined as:
- Absolute neutrophil count (ANC) >=1.5 × 10(9)/L
- Hemoglobin >=9 g/dL
- Platelets >=100 × 10(9)/L
11. Adequate hepatic function defined as:
- Albumin >=3 g/dL
- Serum total bilirubin <=1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=1.5 × ULN without liver metastases; <=5 × ULN if documented liver metastases
12. Adequate renal function defined as:
- Serum creatinine <=1.5 x ULN or calculated creatinine clearance (cCrCl) per Cockcroft-Gault formula >= 50mL/min
13. Negative serum human chorionic gonadotropin pregnancy test at study entry for patients of childbearing potential. Patients of reproductive potential must agree to use adequate contraception for the duration of study treatment and for 30 days after the last dose of study drug
14. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1. Predominantly squamous, adenosquamous histology, or unclear histologic type
2. Prior maintenance therapy with an investigational anticancer agent
3. Prior treatment with tyrosine kinase inhibitors (TKIs) for lung cancer.
4. Patients with tumors known to harbor molecular alterations for which a targeted therapy is locally approved.
5. Presence or suspicion of central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis as determined by magnetic resonance imaging/computed tomography (MRI/CT) scan performed at screening.
6. Active malignancies other than NSCLC within the last 5 years except for adequately treated in situ carcinoma of the cervix uteri, or basal or squamous cell carcinoma of the skin
7. Significant weight loss of >=10% body weight within the 4 weeks prior to randomization
8. History of pulmonary hemorrhage or hemoptysis >=Grade 2 within 4 months of randomization
9. Peripheral neuropathy >=Grade 2 at randomization
10. Prior radiotherapy to the only area of measurable disease, unless there is documented disease progression, defined as increase of at least 1 cm in longest diameter compared to nadir scan.
11. Known serious cardiac illness or medical conditions, including but not limited to:
i. History of documented congestive heart failure (CHF), New York Heart Association (NYHA) class II/III/IV (see Appendix V), with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, beta blockers, or diuretics.
ii. Screening QTc (QT interval corrected for heart rate) (cardiac interval from start of Q wave to end of T wave) >470 msec or history of QT prolongation while taking other medications
iii. High-risk uncontrolled arrhythmias (ventricular arrhythmias, high-grade AV-block, supra-ventricular arrhythmias that are not adequately rate-controlled)
iv. Arrhythmias that require current treatment with the following anti-arrhythmic drugs: flecainide, moricizine, or propafenone
v. Current coronary artery disease with a history of myocardial infarction, angioplasty, or coronary bypass surgery within the preceding 6 months, or angina pectoris that has been symptomatic within the preceding 6 months
12. Uncontrolled intercurrent illness including, but not limited to, patients receiving combination antiretroviral therapy or patients with severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements.
13. Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified