The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with Gemcitabine. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic pancreatic adenocarcinoma when it is given with Gemcitabine. Gemcitabine is approved by the FDA for metastatic pancreatic adenocarcinoma.
- Conditions
- Metastatic Pancreatic AdenocarcinomaMedDRA version: 14.1Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-003753-26-DE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 244
1. Willingness to sign the subject informed consent
2. Initial diagnosis of metastatic pancreatic cancer must have occurred = 6 weeks
prior to the completion of screening
3. The presence of measurable metastatic pancreatic cancer documented
by contrast enhanced CT (or MRI) scan in addition to 1 of the
following:
a) Histological diagnosis of pancreatic adenocarcinoma confirmed by
pathologist OR
b) Pathologist confirmed histological/cytological diagnosis of
adenocarcinoma consistent with pancreatic origin in conjunction with
either:
(1) The presence of a mass in the pancreas OR
(2) A history of resected pancreatic carcinoma
4. Measurable disease per RECIST (ver. 1.1), defined with all of
following criteria:
a) Lesions accurately measured in at least 1 dimension
b) The longest diameter in the plane of measurement is to be recorded
c) A minimum size of 10 mm if CT slice thickness = 5 mm; if
thickness is > 5 mm then the minimum size of measurable lesions
should be twice slice thickness
5. Male or female =18 years of age
6. ECOG Performance Status of 0 or 1
7. Women of childbearing potential must agree to use 1 medically
approved (i.e., mechanical or pharmacological) contraceptive measure
and have their partners agree to an additional barrier method of
contraception for the duration of the study and for 90 days after the last
administration of study drug
8. Male subjects must agree to use protocol-recommended methods of
contraception during heterosexual intercourse and avoid sperm donation
for the duration of this study and for 6 months after the last dose of
gemcitabine.
9. Adequate organ function defined as follows:
a. Hematological: Platelets =100 x 109/L; Hemoglobin =9.0 g/dL;
Absolute Neutrophil
Count (ANC) =1.5 x 109/L
b. Hepatic: AST/ALT =2.5 x ULN (if liver metastases are present, =5 x
ULN); Total or conjugated bilirubin =1.5 x ULN
c. Renal: Serum Creatinine =1.5 x ULN OR creatinine clearance = 60
ml/minute as calculated by the Cockroft-Gault method
10. Coagulation: International Normalized Ratio (INR) = 1.6 (unless
receiving anticoagulation therapy). Patients on full-dose anticoagulation
must be on a stable dose (minimum duration 14 days) of oral
anticoagulant or low molecular weight heparin. If receiving warfarin, the
patient must have an INR = 3.0 and no active bleeding (ie, no bleeding
within 14 days prior to first dose of study therapy).
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 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas or clinical significant laboratory finding that in the investigator’s judgment would pose a risk to subject
safety, interfere with study procedures, or prevent completion of the study
2. A diagnosis of pancreatic islet neoplasms
3. Subject has undergone major surgery other than diagnosis surgery within 4 weeks of enrollment (Part A)/ randomization (Part B)
4. Subjects for whom combination treatment with erlotinib and gemcitabine was planned
5. Subjects with biliary obstruction requiring external drainage
6. Pregnant or lactating
7. Known or suspected cerebral metastases
8. History or presence of any form of cancer, other than pancreatic
cancer, within the 3 years prior to enrollment, with the exception of
excised basal cell or squamous cell carcinoma of the skin, stage 0 or 1
melanoma, or cervical carcinoma in situ or breast carcinoma in situ that
has been excised or resected completely and is without evidence of local
recurrence or metastasis.
9. Unstable cardiovascular function including but not limited to: myocardial infarction within the last 6 months of screening, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
10. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
11. Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
12. Known HIV infection
13. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ngoing signs/symptoms related to the infection and without improvement) despite appropriate
antibiotics use
14. Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed
15. Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study Day 1 of Cycle 1 or within 5 times the half-life of the investigational drug in the other clinical
study, if known, whichever is shorter
16. Known hypersensitivity to the study investigational medicinal products or formulation excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the additive efficacy of GS-6624 vs. placebo in combination<br>with gemcitabine as measured by improvement in progression free<br>survival (PFS);Secondary Objective: To compare the additive efficacy of GS-6624 vs. placebo in combination<br>with gemcitabine as measured by<br>• Overall Survival (OS)<br>• Objective response rate (by modified RECIST version 1.1);Primary end point(s): Progression free survival ;Timepoint(s) of evaluation of this end point: Progression free survival is the primary endpoint is measured as time from<br>date of randomization to the earliest event time of a) death regardless of cause, or b) first<br>indication of disease progression.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall Survival<br>Objective response rate (by modified RECIST version 1.1);Timepoint(s) of evaluation of this end point: Overall survival is measured as time from date of randomization to death regardless of cause.