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A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer (PROTACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01676259
Recruitment Status : Recruiting
First Posted : August 30, 2012
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Silenseed Ltd

Tracking Information
First Submitted Date  ICMJE August 28, 2012
First Posted Date  ICMJE August 30, 2012
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE March 7, 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2012)
Progression-free survival (PFS) in the study population [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer
Official Title  ICMJE Phase 2 Study Evaluating the Efficacy,Safety,Tolerability and PK of siG12D-LODER in the Treatment of Patients With Unresectable LAPC When Used in Conjunction With Standard Chemotherapy (Gemcitabine+Nab-Paclitaxel) Versus Chemotherapy Alone
Brief Summary

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable locally advanced pancreatic cancer combined with chemotherapy treatment.

Primary Outcome:

- Progression-free survival (PFS) in the study population.

Detailed Description

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable LAPC combined with chemotherapy treatment (Gemcitabine+nab-Paclitaxel). This will be the first study to assess the response rate of the siG12D-LODER in patients with unresectable LAPC. The study is of a two-arm design with one arm receiving siG12D-LODER + chemotherapy, and the other arm receiving only chemotherapy.

The investigational agent siG12D-LODER is a miniature biodegradable bio polymeric matrix that encompasses the drug, designed and produced by Silenseed Ltd. The implantation of LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.

siG12D-LODER has been studied in the escalating dose Phase I study of 15 patients, and results showed high safety and tolerability profiles, with no single DLT.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
Intervention  ICMJE
  • Drug: siG12D-LODER
    The implantation of siG12D-LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.
  • Drug: Gemcitabine+nab-Paclitaxel
    Gemcitabine+nab-Paclitaxel
    Other Name: Chemotherapy
Study Arms  ICMJE
  • Active Comparator: Chemotherapy
    Gemcitabine+nab-Paclitaxel
    Intervention: Drug: Gemcitabine+nab-Paclitaxel
  • Experimental: siG12D-LODER + chemotherapy
    Eight siG12D-LODER+(Gemcitabine+nab-Paclitaxel)
    Interventions:
    • Drug: siG12D-LODER
    • Drug: Gemcitabine+nab-Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2012)
98
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who provide written informed consent to participate in the study
  • Men and women patients 18 years of age and up
  • Have an unresectable, locally advanced pancreatic cancer (AJCC stage III). (Excluded: resectable and borderline resectable patients are ineligible per NCCN criteria)
  • Allocated to receive Gemcitabine + nab-Paclitaxel as first line treatment.
  • Have a target tumor that is accessible for intratumoral administration by EUS (Endoscopic Ultrasound) guidance as determined by the radiologist/gastroenterologist performing the EUS insertion.
  • Have an ECOG performance status of ≤ 1
  • If female and of childbearing potential, have a negative serum or urine pregnancy test during screening. Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.
  • Have serum creatinine <1.6 mg/dL, INR < 1.5 U, absolute neutrophil count (ANC) > 1.5 x 109/L , platelets ≥ 100 x 109/L , hemoglobin ≥ 9 mg/dL, ALT and AST ≤ 5 x ULN, bilirubin ≤ 1.5 x ULN
  • Have measurable disease. Patients must have clinically and/or radiographically documented measurable primary disease according to RECIST 1.1. At least one site of disease must be unidimensionally measurable. All radiology scans must be performed within 28 days prior to registration

Exclusion Criteria:

  • Subjects with resectable and borderline resectable pancreatic cancer
  • Evidence of metastatic disease
  • Other malignancy that would interfere with the current intervention
  • Any evidence of ascites (beyond trace)
  • Bulky celiac adenopathy (≥2.5 cm) or nonadenocarcinoma histology.
  • Any prior therapy for the treatment of pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  • Prior therapy with any hypoxic cytotoxin (hypoxia-targeting drugs).
  • Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years
  • Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
  • History of clinically significant coagulopathy
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
  • New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 4months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Subjects who participated in an investigational drug or device study within 28 days prior to study entry
  • Known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • Females who are pregnant or breast-feeding
  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any reason
  • Known allergy to sesame oil
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Orit Pollack-Shragai, MSc, MBA +972-52-8466267 orit@silenseed.com
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01676259
Other Study ID Numbers  ICMJE SLSG12D-P2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silenseed Ltd
Study Sponsor  ICMJE Silenseed Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eileen M O'Reilly, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Talia Golan, MD Sheba Medical Center
PRS Account Silenseed Ltd
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP