A clinical trial with Gemcitabine and Nab-paclitaxel combined with Momelotinib in Subjects with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- ntreated Metastatic Pancreatic Ductal AdenocarcinomaMedDRA version: 17.1Level: PTClassification code 10073364Term: Ductal adenocarcinoma of pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004480-20-HU
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1) Age = 18 years old
2) Initial diagnosis of metastatic pancreatic adenocarcinoma must have occurred = 6 weeks prior to enrollment
3) The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
- Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
- Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either:
- The presence of a mass in the pancreas, OR
- A history of resected pancreatic adenocarcinoma
4) Measurable disease per RECIST v1.1
5) Adequate organ function defined as follows:
- Hepatic: Total bilirubin < upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) = 3 x upper limit of normal (ULN)
- Hematological: Absolute neutrophil count (ANC) > 1500 cells/mm3, platelet > 100,000 cells/mm3, hemoglobin > 9 g/dL
- Renal: Serum creatinine < ULN OR calculated creatinine clearance (CrCl) = 60 ml/min as calculated by the Cockroft-Gault method
6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
7) mGPS of 1 or 2 at Screening (randomized phase only)
8) Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years postmenopausal)
9) Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 3
10) Females who are nursing must agree to discontinue nursing before the first dose of investigational product (IP)
11) Able to comprehend and willing to sign the written informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
1) Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
2) Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic
pancreatic carcinoma
3) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active or chronic bleeding event within 4 weeks prior to first dose of IP, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
4) History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for = 1 year prior to enrollment, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for = 5 years
5) Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days of first dose of IP
6) Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous
access device, fine needle aspiration, or endoscopic biliary stent = 1 day before enrollment is acceptable)
7) Known positive status for human immunodeficiency virus (HIV)
8) Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
9) Peripheral neuropathy = Grade 2
10) Known or suspected brain or central nervous system metastases
11) Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or cystadenocarcinoma
12) History of interstitial pneumonitis and/or require supplemental oxygen therapy
13) External biliary drain
14) Documented myocardial infarction or unstable/uncontrolled cardiac disease (ie, unstable angina, congestive heart failure [New York Heart Association > Class III]) within 6 months of enrollment
15) Use of strong CYP3A4 inducers within 1 week prior to the first dose of IP
16) Known hypersensitivity to MMB, gemcitabine and/or nab-paclitaxel, their metabolites, or formulation excipients
17) Uncontrolled hypertension (seated systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at Screening
18) QTcF interval > 450 msec, unless attributed to bundle branch block
19) Pregnant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method