Safety Study of CALAA-01 to Treat Solid Tumor Cancers
Stopped early · Phase 1
Conditions studied: Cancer, Solid Tumor
In brief
Rationale: CALAA-01 is a targeted therapeutic designed to inhibit tumor growth and/or reduce tumor size. The active ingredient in CALAA-01 is a small interfering RNA (siRNA). This siRNA inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation within a stabilized nanoparticle targeted to tumor cells. PURPOSE: This phase I trial will: * Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CALAA-01 when administered intravenously to patients with relapsed or refractory cancer. * Characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration. * Provide preliminary evidence of efficacy of intravenous CALAA-01 by evaluating tumor response. * Recommend a dose of intravenous CALAA-01 for future clinical studies. * Evaluate immune response, by measuring antibody and cytokine levels, and the effect of intravenous CALAA-01 on complement.
Key facts
- Study ID
- NCT00689065
- Run by
- Calando Pharmaceuticals
- People needed
- 24
- Starts
- 2008-05-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2013-11-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
- START (South Texas Accelerated Research Therapeutics) — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.