Status:
TERMINATED
QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
NantCell, Inc.
Conditions:
Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)." Part 1, the phase 1b portio...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Histologically or cytologically confirmed SCLC
- Extensive disease, defined by at least one of the following:
- No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
- Extrathoracic metastases
- Malignant pericardial or pleural effusion
- Contralateral hilar adenopathy
- Measurable or nonmeasurable disease, as defined by modified RECIST
- Eastern Cooperative Oncology Group (ECOG) status 0 or 1
- ≥18 years old
- Life expectancy (with therapy) ≥3 months
- Adequate hematologic, hepatic, coagulation, renal, and metabolic function
- Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL
- Key Exclusion Criteria
- Prior chemotherapy, chemoradiation, or investigational agent for SCLC
- Prior radiotherapy to \>25% of the bone marrow
- Symptomatic or untreated central nervous system metastases (with exceptions)
- Currently or previously treated with biologic, immunologic or other therapies for SCLC
- Current serious or nonhealing wound or ulcer
- History of prior concurrent other malignancy (with exceptions)
- Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
- Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity
Exclusion
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00791154
Start Date
December 2 2008
End Date
May 1 2013
Last Update
August 23 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.