Extensive-Stage Small Cell Lung Cancer (ES-SCLC) MedDRA version: 9.1 Level: LLT Classification code 10041068 Term: Small cell lung cancer extensive stage
Conditions
Interventions
Product Name: Obatoclax mesylate
Product Code: GX15-070MS
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Obatoclax mesylate
CAS Number: 803712-79-0
Current Sp
Sponsors
Gemin X Pharmaceuticals US, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I: (a) Pathological or cytological confirmation of SCLC; (b) ES-SCLC; (c) Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) with at least one lesion =2.0 cm using conventional technique or =1.0 cm with spiral computed tomography (CT) scan in a single dimension; (d) No previous chemotherapy; (e) Age =18 years; (f) Eastern Cooperative Oncology Group (ECOG) Performance Status =1; (g) Normal organ function defined as: absolute neutrophil count (ANC) =1500/mm3, platelets =100,000/mm3, total bilirubin = upper limit of normal (ULN) or total bilirubin = 3.0 if liver metastases are present, alanine aminotransferase (serum glutamic pyruvic transaminase) (ALT [SGPT]) =2.5 x ULN or ALT/SGPT = 5 x ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance =50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; (h) Negative serum or urine pregnancy test result prior to study entry. Women of child-bearing potential and men with partners of child-bearing potential must use a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner;; (i) Ability to understand and willingness to sign a written informed consent form. Phase II: (a) Pathological or cytological confirmation of SCLC; (b) ES-SCLC; (c) Measurable disease using RECIST criteria with at least one lesion =2.0 cm using conventional technique or =1.0 cm with spiral CT scan in a single dimension; (d) No previous chemotherapy; (e) Age =18 years; (f) ECOG Performance Status =2; (g) Normal organ function defined as: ANC =1500/mm3, platelets =100,000/mm3, total bilirubin =ULN or total bilirubin = 3.0 if liver metastases are present, ALT (SGPT) =2.5 x ULN or ALT/SGPT = 5 x ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance =50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; (h) Negative serum or urine pregnancy test result prior to study entry. Women of child-bearing potential and men with partners of child-bearing potential must use a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner; (i) Ability to understand and willingness to sign a written informed consent form. 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: Phase I and II: (a) Other investigational or commercial agents or therapies administered with the intent to treat the patient’s malignancy; (b) History of allergic reactions attributed to components of the obatoclax formulation (Polysorbate 20 and PEG 300); (c) History of seizure disorders unrelated to SCLC brain metastases, or presence of symptomatic brain metastases; (d) Uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements; (e) Pregnant women and women who are breast feeding; (f) human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: Determine the recommended Phase II dose of obatoclax administered as a 3-hour infusion on 3 consecutive days and, in a separate obatoclax dose escalation, as a 72-hour infusion, every 21 days in combination with carboplatin and etoposide Phase II: Compare the overall response rate of the 2 treatment arms • Carboplatin, etoposide, and obatoclax as a 3-hour infusion on 3 consecutive days • Carboplatin and etoposide alone ;Secondary Objective: Phase I: Characterize the safety profile of obatoclax, administered as a 3-hour infusion on 3 consecutive days and as a 72-hour infusion, in combination with carboplatin and etoposide Phase II: • Compare the progression-free survival (PFS) of the 2 treatment arms • Compare the complete response (CR) rates of the 2 treatment arms • Compare the overall survival (OS) of the 2 treatment arms • Compare the safety profile of the 2 treatment arms • Compare changes in pulmonary function tests (PFTs) from baseline across the 2 treatment arms • Evaluate pharmacodynamic markers in the 2 treatment arms ;Primary end point(s): Phase I: to establish the MTD of obatoclax when given as either a 3-hour or 72-hour continuous infusion in combination with carboplatin and etoposide. Phase II: The primary analysis of efficacy will be conducted on the rate of overall response (CR and PR) as determined by investigators. Additional, secondary efficacy analyses will be performed on the rate of profression-free survival, on CR, on OS, on the safety profiles of the 2 treatment arms, and on the pharmacodynamic markers evaluated during the trial. | — |
Countries
Bulgaria, Czech Republic, Hungary, United Kingdom
Outcome results
None listed