Clinical trialPhase 1 / Phase 2Terminated
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
Phase 1/2 Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma.
- Outcome
- Stopped earlyStudy was terminated due to cease in manufacturing of study drug. (Other)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 27 December 2011
- Expected end
- 5 November 2018
- Enrollment
- 23 participants
- Sites
- 1
- Primary outcomes
- Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225; Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA
- Sponsor
- Other
- Results posted
- 2019-06-25
- Last update
- 22 January 2020
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Brief summary public domain (ClinicalTrials.gov)
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.
Detailed description public domain (ClinicalTrials.gov)
The investigators propose treating 6-12 patients during the phase 1 portion and 40 patients in the phase 2 stage. Phase 1 Stage: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with escalating doses (400mg, or 600mg, or 800mg) of LDE-225. After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 in combination with LDE-225. Phase 2 Stage: In the Phase 2 stage the patients will be randomized to receive gemcitabine and nab-paclitaxel with or without the hedgehog inhibitor LDE225: 1. Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. 2. Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15. After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of the pre-surgical therapy. Several correlative laboratory studies will be conducted during the course of this study. They were designed around the goals of providing us with a better understanding of how the stroma-tumor interaction and the intra-tumoral drug levels of gemcitabine are affected with the use of LDE-225. Two additional biopsies are required to participate in this study.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225 [5 years]. Count Of Participants, Participants. Phase I: Gem, Nab-paclitaxel, and LDE225-600mg (n=13): 13; Phase I: Gem, Nab-paclitaxel, and LDE225-400mg (n=0): 0; Phase I: Gem, Nab-paclitaxel, and LDE225-800mg (n=0): 0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA [5 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [5 years]. Median, months (Full Range). Phase I: Gem, Nab-paclitaxel, and LDE225-600mg (n=13): 34.3 (3.7 to 60).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response [5 years]. Count Of Participants, Participants. Phase I: Gem, Nab-paclitaxel, and LDE225-600mg (n=13): 3.