A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Study summary

The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedObatoclax and Carboplatin/etoposide

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 21, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?75 U.S. locations

Locations may change over time.

Who runs it?Gemin X

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Gemin X
Interventions being studied: Drug: Obatoclax; Drug: Carboplatin/etoposide

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Phase I:
Pathological or cytological confirmation of SCLC
ES-SCLC
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
No previous chemotherapy
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
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 ´ ULN or ALT/SGPT ≤ 5 ´ 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
Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
Ability to understand and willingness to sign a written informed consent form Phase II:
Pathological or cytological confirmation of SCLC
ES-SCLC
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
No previous chemotherapy
Age ≥18 years
ECOG Performance Status ≤2;
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, and creatinine within normal institutional limits or calculated creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
Ability to understand and willingness to sign a written informed consent form

Reasons someone may not be able to joinExclusion criteria

Phase I and II:
Other investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy
History of allergic reactions attributed to components of the obatoclax formulation (Polysorbate 20 and PEG 300)
History of seizure disorders unrelated to SCLC brain metastases, or presence of symptomatic brain metastases
Uncontrolled,intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled systemic infection considered opportunistic, lifethreatening,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
Pregnant women and women who are breast feeding;
human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Clearview Cancer InstituteHuntsville, Alabama
Northwest Alabama Cancer CenterMuscle Shoals, Alabama
Mayo Clinic-ArizonaScottsdale, Arizona
Arizona Clinical Research CenterTucson, Arizona
City of Hope and Beckman Research InstituteDuarte, California
University of California-San Diego Moores Cancer CenterLa Jolla, California
Georgetown University Hospital-Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
Integrated Community Oncology NetworkJacksonville, Florida
University of Miami-Sylvester Cancer CenterMiami, Florida
Florida Cancer InstituteNew Port Richey, Florida
H. Lee Moffitt Cancer CenterTampa, Florida
Northwest Georgia Oncology CentersMarietta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2016. Always confirm current availability with the study team.

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