Advanced Solid Tumors Clinical Trial
Official title:
Dose-finding Study of CAELYXTM and RAD001 in Patients With Advanced Solid Tumors
This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the
Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001
(escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors.
Other purposes of the study are:
1. define the safety profile of the combination after repeated administrations
2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented
expansion phases at the RD.
3. define the pharmacokinetic profile of the combination
mTOR inhibitors are a new class of targeted antitumor agents which showed interesting
antitumor activity in a variety of solid tumors, including prostate, soft tissue sarcomas ,
ovarian, endometrial, kidney, and breast cancer. They also exert an antiangiogenic effect
and are almost devoid of bone marrow toxicity as single agents which makes them suitable for
combination with cytotoxic drugs.
Anthracyclines are among the most used and effective cytotoxic agents, and in solid tumors
their indications include, among others, breast, ovary, endometrial, prostate cancer.
Liposomal Doxorubicin (CaelyxTM) could be an adequate replacement of doxorubicin to avoid
potential side effects such as cardiotoxicity, alopecia, GI toxicity.
Testing a combination regimen including mTOR inhibitors and anthracyclines in those tumors
which are known to be sensitive to both compounds is of high clinical interest and
worthwhile.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
| Active, not recruiting |
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