Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
This is a single-arm, open-label, phase Ib study. In this trial, patients with Triple
Negative (TN) Advanced Breast Cancer (ABC) will be treated with increasing doses of LDE225
(sonidegib) and docetaxel to determine the Maximum Tolerated Dose (MTD), Dose Limiting
Toxicity (DLT) and Recommended Phase II Dose (RP2D) of the combination.
Eligible patients with hormonal receptors negative and Human Epidermal Growth Factor Receptor
2 (HER2) negative ABC will be included and treated with docetaxel intravenously in every
three weeks cycles. LDE225 will be administered orally at three dose levels 400, 600 and
800mg one a day (QD) (a -1 dose level is included just in case dose de-escalation is needed).
Treatment will be repeated on day 1 of a 21-day cycle until radiographic or symptomatic
progression, unacceptable toxicity or withdraws informed consent.
The investigators propose to develop a phase Ib trial with the combination of docetaxel with
LDE225 in TN ABC patients to define the safety, tolerability and RP2D, as well as to have
some information about the efficacy of the combination.