A Phase II study in patients with Extensive-Stage Small Cell Lung Cancer.

Phase 2

Completed

• Registration Number: CTRI/2009/091/000875
• Lead Sponsor: Gemin X Pharmaceuticals US Inc Chesterfield ParkwaySuite Malvern PA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

a) Pathological or cytological confirmation of SCLC
b) ES-SCLC (refer to Appendix 16.4)[27]
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 × ULN; or ALT/SGPT ≤ 5 × ULN if liver metastases are present
? 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 childbearing 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

Exclusion Criteria

Exclusion Criteria:
Patients are excluded from this study if any of the following criteria apply:
Phase I and II
a) Other investigational or commercial agents or therapies are being 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 antiretroviral therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the overall response rate of the 2 treatment arms<br>Carboplatin, etoposide, and obatoclax as a 3-hour infusion on 3 consecutive days<br>Carboplatin and etoposide aloneTimepoint: 18 weeks

Secondary Outcome Measures

Name	Time	Method
Compare the progression-free survival (PFS) of the 2 treatment arms<br>Compare the complete response (CR) rates of the 2 treatment arms<br>Compare the overall survival (OS) of the 2 treatment arms<br>Compare the safety profile of the 2 treatment arms<br>Compare changes in pulmonary function tests (PFTs) from baseline across the 2 treatment arms<br>Evaluate pharmacodynamic markers in the 2 treatment armsTimepoint: 15 months