LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02138929|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Everolimus Drug: LDE 225||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of LDE225 in Combination With Everolimus in Patients With Advanced Gastroesophageal Adenocarcinoma|
|Actual Study Start Date :||November 10, 2014|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Everolimus + LDE 225
Dose Escalation: Everolimus at a dose of 10 mg by mouth daily with dose escalation of LDE 225 from 200 mg - 800mg by mouth daily. Study cycle is 28 days.
Dose Expansion: Everolimus at a dose of 10 mg by mouth daily. LDE 225 at MTD from Dose Escalation. Study cycle is 28 days.
Induction and Dose Expansion Phase: 10 mg by mouth daily in a 28 day cycle.
Drug: LDE 225
Induction Phase Starting Dose: 400 mg by mouth daily in a 28 day cycle.
Expansion Phase Starting Dose: Maximum tolerated dose from Induction Phase.
- Maximum Tolerated Dose (MTD) of LDE225 in Combination with Everolimus in Participants with Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction (GEJ) or Stomach in the Second or Third Line Setting [ Time Frame: 10 weeks ]Maximum tolerated dose (MTD) defined as highest dose level for the combination therapy with no more than 1 out of 6 patients experiencing dose limiting toxicity (DLT). DLT defined as an adverse event (AE) or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤56 days following the first dose of LDE225 (DLT assessment period).
- Safety of LDE225 in Combination with Everolimus in a Cohort of Participants with Metastatic Nuclear Gli-1 Expressing Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach per CTCAE. [ Time Frame: 30 days after last dose of study drug given. ]A Bayesian method by Thall, Simon, and Estey  used for safety monitoring, starting from the 5th patient. The monitoring rule for toxicity is Pr (P(Tox) > 0.25 | data) > 0.80, where P(Tox) is the proportion of patients that experience DLT and it has a prior distribution of beta (0.5, 1.5).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138929
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jaffer Ajani, MD||M.D. Anderson Cancer Center|