Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer MedDRA version: 9.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV MedDRA version: 9.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Product Name: KOS-1584
Product Code: KOS-1584
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: (E)-9,10-didehydroepothilone D
CAS Number: 350493-61-7
Current Sponsor code: KOS-1584
Conce
Sponsors
KOSAN BIOSCIENCES, INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Current diagnosis of histologically or cytologically proven NSCLC, Stage IIIB or Stage IV, according to the American Joint Committee on Cancer (AJCC) staging system. Disease must not be amenable to curative therapy either by maximally feasible surgical resection or radiotherapy. Eligible patients must have received only one prior chemotherapy regimen for Stage IIIB/IV NSCLC. 2. Age greater than or equal to 18 years. 3. ECOG performance status 0 or 1. 4.Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, as per RECIST criteria. Tumor measurements must be assessed by RECIST within 28 days prior to first study drug administration. 5. All clinically significant adverse events, excluding alopecia, of any prior chemotherapy, surgery or radiotherapy must have resolved to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade less than or equal to 1. A minimum of 3 weeks must occur between last administration of chemotherapy, radiotherapy, or surgery and first study drug administration. 6. The following laboratory results, within 10 days of first study drug administration: Hemoglobin greater than or equal to 8.5 g/dL (85 g/L) Absolute neutrophil count greater than or equal to 1.5 x 10 to the 9/L Platelet count greater than or equal to 75 x 10 to the 9/L Serum bilirubin less than or equal to 1.5 x ULN AST and ALT less than or equal to 2.5 x ULN (less than or equal to 5 x ULN in case of hepatic metastases) 7. Women of child bearing potential: negative pregnancy test (serum or urine). Female patients must be >1 year postmenopausal, surgically sterile or they must agree to use a physical method of contraception. Male patients must be surgically sterile or must agree to use an acceptable method of contraception. 8. Signed informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Neurological disease (including but not limited to peripheral sensory or motor neuropathy, seizures, gait disturbances, or tremors/involuntary movements) of CTCAE Grade greater than or equal to 2 due to any cause at time of screening; pre-existing painful neuropathy which at the time of screening is of CTCAE Grade greater than or equal to 1. 2. Prior treatment with an epothilone. 3. Pre-existing diarrhea uncontrolled with supportive care. Prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause. Active, uncontrolled peptic ulcer disease (patients maintained with omeprazole, ranitidine or famotidine are acceptable to enroll). 4. Presence of clinically or radiologically detectable (by physical examination) third-space fluid collections (e.g., pleural and/or peritoneal effusions) unless these can be controlled by drainage at a frequency of not more than once every 2 weeks prior to first study drug administration. 5. Documented hypersensitivity reaction (NCI CTCAE Grade greater than or equal 2) to prior therapy containing hydroxypropyl-ß-cyclodextrin, ethanol, and propylene glycol. 6. Current history of ethanol abuse or concomitant administration of Antabuse® (disulfiram). 7. Pregnant or breast-feeding women. 8. Known CNS metastases. A patient with focal neurological deficits identified during the screening period must undergo baseline CT or MRI with contrast of the head to investigate possible CNS metastases. 9. Administration of any investigational agent (therapeutic or diagnostic) including any investigational compound for the treatment of NSCLC, within 3 weeks prior to first study drug administration. 10. Any medical condition that would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, uncontrolled dysrhythmia, infection requiring parenteral or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent. 11. Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or treated carcinoma-in-situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the Objective Response Rate (ORR) of KOS-1584 as a single agent, administered weekly for 2 weeks out of every 3 weeks intravenously in patients with stage IIIB/IV NSCLC whose disease has progressed following initial chemotherapy;Secondary Objective: To evaluate KOS-1584 for Progression Free Survival (PFS), Time To Progression (TTP), Time To Treatment Failure (TTF), time to response, duration of response, and overall survival. To evaluate separately the safety of KOS-1584. ;Primary end point(s): Response rate (based on tumor measurements according to RECIST criteria) Duration of response, time to response PFS, TTP, TTF, survival (both overall and patients with CR/PR/Stable Disease (SD)) Adverse events reported by the patients or noted during physical examination and laboratory tests results. | — |
Countries
Germany
Outcome results
None listed