Pancreatic Ductal AdenocarcinomaPhase 1/2NCT01431794
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
A Phase 1/2 study testing LDE225-600mg, Gemcitabine and nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- LDE225-600mg, Gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2011to 5 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- Must have borderline resectable pancreatic adenocarcinoma
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- No previous radiotherapy, surgery, chemotherapy or investigational drug therapy.
- Age >18 years
- Life expectancy of greater than 1 month.
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- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
- Adequate organ and marrow function
- Asymptomatic for jaundice and ascites. Pain symptoms should be stable.
- Negative serum pregnancy test
- Sexually active males should agree to use a barrier form of contraception, even if they have had a vasectomy, during the study and for 6 months after stopping LDE225. Males should not donate sperm during treatment, and for up to six months after last dose. Sexually active females of child bearing potential agree to using highly effective contraception during study and for 20 months after final dose of LDE225.
- Agree not to donate blood products for 12 months after stopping LDE225.
- Willing to have two biopsies while on treatment for correlative studies.
Who cannot join
- Patients who have had previous radiotherapy, surgical resection, chemotherapy or investigational drug therapy for pancreatic adenocarcinoma.
- Patient has known metastatic disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LDE225 or other agents used in the study.
- Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
- Uncontrolled illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure not controlled with medication, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded
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- Patient has undergone a major surgery, other than diagnostic surgery within four weeks prior to starting treatment on this study.
- Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.
- Patients with neuromuscular disorders.
- Patients with impaired cardiac function.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: 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.
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.
Read the detailed description
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:
- 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.
- 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- LDE225-600mg, Gemcitabine, nab-paclitaxel, LDE225-400mg, LDE225-800mg
- Keywords
- Pancreatic ductal adenocarcinoma (PDA)Neoplasms, LDE225, nab-paclitaxel, abraxane, gemcitabine, neoadjuvant, cytotoxic, hedgehog inhibitor, stromal cells, resectable PDA, Pancreatic Diseases, Carcinoma, Sonidegib
- Medical subject headings
- Pancreatic Diseases, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDE225-600mgDrug
Also called Sonidegib
Phase I: oral LDE225 (Sonidegib), 600mg daily.
Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.
GemcitabineDrug
Also called gem
Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.
nab-paclitaxelDrug
Also called abraxane
Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.
LDE225-400mgDrug
Also called Sonidegib
Phase I: oral LDE225 (Sonidegib), 400mg daily.
LDE225-800mgDrug
Also called Sonidegib
Phase I: oral LDE225 (Sonidegib), 800mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Phase I-Gem,nab-paclitaxel,LDE225-600mg | Experimental | Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily. Receives: Drug: LDE225-600mg; Drug: Gemcitabine; Drug: nab-paclitaxel |
| Phase II-Arm A:Gem,nab-paclitaxel,LDE225 | Active comparator | Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days. Receives: Drug: LDE225-600mg; Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: LDE225-400mg; Drug: LDE225-800mg |
| Phase II-Arm B:Gem,nab-paclitaxel | Active comparator | Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days. Receives: Drug: Gemcitabine; Drug: nab-paclitaxel |
| Phase I-Gem,nab-paclitaxel,LDE225-400mg | Experimental | Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily. Receives: Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: LDE225-400mg |
| Phase I-Gem,nab-paclitaxel,LDE225-800mg | Experimental | Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily. Receives: Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: LDE225-800mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).
Measured: 5 years
Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA
Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy
Measured: 5 years
Secondary outcomes (2)
Overall Survival
Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first.
Measured: 5 years
Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response
Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study start27 Dec 2011
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Why it stopped: Study was terminated due to cease in manufacturing of study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, The Skip Viragh Foundation
- Responsible party
- Sponsor
- Investigators
- Ana De Jesus-Acosta, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center JHMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431794
- Sponsor's protocol ID
- J1130
- Other IDs
- NA_00047491
- Status last verified
- Jan 2020
- First submitted
- 19 Jul 2011
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01431794
- Acronym / sponsor ID
- J1130
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic ductal adenocarcinoma (PDA)Neoplasms, LDE225, nab-paclitaxel, abraxane, gemcitabine, neoadjuvant, cytotoxic, hedgehog inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to cease in manufacturing of study drug.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, The Skip Viragh Foundation
- Study start
- 27 Dec 2011 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I-Gem,nab-paclitaxel,LDE225-600mg | Experimental | Drug: LDE225-600mg, Drug: Gemcitabine, Drug: nab-paclitaxelFour cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily. |
| Phase II-Arm A:Gem,nab-paclitaxel,LDE225 | Active comparator | Drug: LDE225-600mg, Drug: Gemcitabine, Drug: nab-paclitaxel, Drug: LDE225-400mg, Drug: LDE225-800mgFour cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days. |
| Phase II-Arm B:Gem,nab-paclitaxel | Active comparator | Drug: Gemcitabine, Drug: nab-paclitaxelFour cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days. |
| Phase I-Gem,nab-paclitaxel,LDE225-400mg | Experimental | Drug: Gemcitabine, Drug: nab-paclitaxel, Drug: LDE225-400mgFour cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily. |
| Phase I-Gem,nab-paclitaxel,LDE225-800mg | Experimental | Drug: Gemcitabine, Drug: nab-paclitaxel, Drug: LDE225-800mgFour cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- Must have borderline resectable pancreatic adenocarcinoma
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- No previous radiotherapy, surgery, chemotherapy or investigational drug therapy.
- Age >18 years
Key exclusion criteria (10 listed)
- Patients who have had previous radiotherapy, surgical resection, chemotherapy or investigational drug therapy for pancreatic adenocarcinoma.
- Patient has known metastatic disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LDE225 or other agents used in the study.
- Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
- Uncontrolled illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure not controlled with medication, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDE225-600mgAlso: SonidegibPhase I: oral LDE225 (Sonidegib), 600mg daily. Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days. | Drug | Phase I-Gem,nab-paclitaxel,LDE225-600mg, Phase II-Arm A:Gem,nab-paclitaxel,LDE225 |
| GemcitabineAlso: gemFour cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days. | Drug | Phase I-Gem,nab-paclitaxel,LDE225-400mg, Phase I-Gem,nab-paclitaxel,LDE225-600mg, Phase I-Gem,nab-paclitaxel,LDE225-800mg, Phase II-Arm A:Gem,nab-paclitaxel,LDE225, Phase II-Arm B:Gem,nab-paclitaxel |
| nab-paclitaxelAlso: abraxaneFour cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days. | Drug | Phase I-Gem,nab-paclitaxel,LDE225-400mg, Phase I-Gem,nab-paclitaxel,LDE225-600mg, Phase I-Gem,nab-paclitaxel,LDE225-800mg, Phase II-Arm A:Gem,nab-paclitaxel,LDE225, Phase II-Arm B:Gem,nab-paclitaxel |
| LDE225-400mgAlso: SonidegibPhase I: oral LDE225 (Sonidegib), 400mg daily. | Drug | Phase I-Gem,nab-paclitaxel,LDE225-400mg, Phase II-Arm A:Gem,nab-paclitaxel,LDE225 |
| LDE225-800mgAlso: SonidegibPhase I: oral LDE225 (Sonidegib), 800mg daily. | Drug | Phase I-Gem,nab-paclitaxel,LDE225-800mg, Phase II-Arm A:Gem,nab-paclitaxel,LDE225 |
Primary outcome
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
Time frame: 5 years
Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).
Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA
Time frame: 5 years
Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy
2 secondary outcomes
Overall Survival
Time frame: 5 years
Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana De Jesus-Acosta, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center JHMI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LDE225-600mg, Gemcitabine and nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.