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IMOxine in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
NCT00729053Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2004
- Primary completion
- Apr 2008
- Countries
- 1
- Sponsor
- Aceragen, Inc.
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), MicroRNA (miRNA)
- Drugs
- IMO-2055
- Conditions
- clear cell renal cell carcinoma (ccRCC)
01
Overview
Phase 2, randomised, open-label trial of IMO-2055 in clear cell renal cell carcinoma (ccRCC) (4 arms), sponsored by Aceragen, Inc. Primary endpoint: Best Response by RECIST v1.0 at 1 year. Started Jun 2004; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Previous treatment, 0.16mg/kg
Weekly SC injections of IMO-2055 at 0.16mg/kg in previously treated patients.
Previous treatment, 0.64mg/kg
Weekly SC injections of IMO-2055 at 0.64mg/kg in previously treated patients.
Treatment Naive, 0.16mg/kg
Weekly SC injections of IMO-2055 at 0.16mg/kg in treatment naive patients.
Treatment Naive, 0.64mg/kg
Weekly SC injections of IMO-2055 at 0.64mg/kg in treatment naive patients.
03
Who it enrols
Patients with histologically confirmed stage IV clear cell renal carcinoma, metastatic or locally recurrent, not surgically resectable, with at least one measurable lesion and adequate organ function. Excludes known untreated CNS metastasis and pre-existing autoimmune diseases.
04
Endpoints
Primary
Best Response by RECIST v1.0
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Duration of Response by RECIST v1.0
Overall Survival at 1 Year
Time to Disease Progression
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