Status:
TERMINATED
A Rollover Protocol for Subjects Previously Treated With AGS-003
Lead Sponsor:
Argos Therapeutics
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
Detailed Description
AGS-003-005 is a rollover, open label, Phase II clinical study testing the biologic activity and safety of AGS-003 in subjects who have experienced either partial responses or prolonged stable disease...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
- Measurable disease that can be monitored per RECIST throughout the course of study participation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic function, as defined by the following criteria:
- White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL)
- Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL)
- Platelets ≥ 100,000/µL (≥ 100 x 103/µL)
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Adequate renal and hepatic function, as defined by the following criteria:
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine \> 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
- Total serum bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
- Adequate coagulation function as defined by the following criteria:
- Prothrombin time (PT) ≤ 1.5 x ULN
- Activated partial thromboplastin time (PTT) \< 1.5 x ULN
- Corrected calcium ≤ 11.5 mg/dL
- Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
- Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- No brain metastases detected by magnetic resonance imaging (MRI).
Exclusion
- Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI
- Pregnancy or breastfeeding
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01482949
Start Date
September 1 2011
End Date
May 1 2018
Last Update
June 27 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455