Advanced Solid Tumors Clinical Trial
Official title:
A Phase IB Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) Given Orally in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumors
The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of Panobinostat (LBH589) when administered in combination with Carboplatin and Paclitaxel in patients with advanced solid malignancies and to identify the Recommended Dose (RD) for a subsequent Phase II study.
The combination of Carboplatin (C) and Paclitaxel (PTX) is considered standard treatment in
patients with epithelial ovarian cancer and endometrial cancer, in USA and in those in whom
anthracyclines are not recommended. In cervical cancer, where very often the renal function
is impaired, C represents a convenient substitute of cisplatin in the combination with PTX;
in NSCLC the C and PTX regimen is first choice therapy for outpatient treatment first or
second line.
LBH is a histone deacetylase (HDAC) inhibitor available also for oral administration.
In combination with platinum agents LBH589 could improve efficacy on DNA by multiple
non-exclusive mechanisms (by increasing drug access to chromosomal DNA, interfering with DNA
repair, modulating the levels of pro antiapoptotic genes or proliferation/survival genes).
The inclusion of Paclitaxel in the combination of LBH589 and Carboplatin is supported by the
results already available with the combination of the HDAC inhibitor Vorinostat
(suberoylanilide hydroxamic acid) given orally with carboplatin (AUC 6 mg/ml.h) and
paclitaxel (200 mg/m2) in a Phase I study in patients with solid tumors. The regimen proved
to be feasible, well tolerated and was associated with promising antitumor activity in
patients with NSCLC.
The mechanism of action, and the preliminary preclinical data, suggest that the combination
of LBH589, Carboplatin and Paclitaxel could be feasible and worthy of clinical
investigation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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