AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy
This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 6, 2019 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Celgene
- Interventions being studied
- Drug: Amrubicin; Drug: Topotecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
- Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
- SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression \>/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression \< 90 days after completing first-line chemotherapy);
- Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
- Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
- No more than 1 prior chemotherapy regimen;
- At least 18 years of age;
- ECOG performance status of 0 - 1
- Chest radiotherapy with curative intent to the primary disease complex \</= 28 days prior to first dose; CNS radiotherapy \</= 21 days prior to first dose; radiotherapy to all other areas \</= 7 days prior to first dose;
- Prior anthracycline, topotecan, or irinotecan treatment.
- Prior anthracycline or topotecan treatment.
- Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northwest Alabama Cancer CenterMuscle Shoals, Alabama
- Arizona Oncology AssociatesTucson, Arizona
- Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas
- Cancer Care Associates of Fresno Medical Group, Inc.Fresno, California
- Cedars-Sinai Outpatient Cancer CenterLos Angeles, California
- University of Colorado Health Science CentreAurora, Colorado
- Rocky Mountain Cancer Center - Midtown (Main)Denver, Colorado
- Advanced Medical SpecialtiesMiami, Florida
- Ocala Oncology CenterOcala, Florida
- Cancer Centers of Florida, P.A.Ocoee, Florida
- Florida Oncology AssociatesOrange Park, Florida
- Sacred Heart Medical OncologyPensacola, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 6, 2019. Always confirm current availability with the study team.