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Safety Study of CALAA-01 to Treat Solid Tumor Cancers

NCT00689065 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-11-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CALAA-01

Subjects with solid tumors who satisfy the eligibility criteria will receive two, 21-day cycles of CALAA-01. A cycle will consist of four (4) 30-minute intravenous infusions administered on days 1, 3, 8, and 10 followed by 11 days of rest. If safe, a second 21-day cycle will be administered consisting of infusions on days 22, 24, 29 and 31 followed by 11 days of rest.

Sponsors & Collaborators

  • Calando Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Antoni Ribas, M.D. · UCLA Jonsson Comprehensive Cancer Center

  • Anthony W Tolcher, M.D. · START (South Texas Accelerated Research Therapeutics)

  • Yun Yen, M.D., Ph.D. · City of Hope National Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689065 on ClinicalTrials.gov