A Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01472198
First received: November 10, 2011
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
This randomized study compares the efficacy of GS-6624 versus placebo in combination with Gemcitabine in subjects with Pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: GS-6624 Drug: Placebo Drug: Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 244 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 700 mg GS-6624 and Gemcitabine (open-label)
Open label, non-randomized treatment period to assess the safety and tolerability of GS-6624 dosed at 700 mg in combination with intravenous (IV) Gemcitabine
|
Drug: GS-6624
700 mg of GS-6624 dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time
|
|
Experimental: 200 mg GS-6624 and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
|
Drug: GS-6624
200 mg of GS-6624 dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time
|
|
Experimental: 700 mg GS-6624 and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
|
Drug: Gemcitabine
dosed weekly for three weeks at a time
Drug: GS-6624
700 mg of GS-6624 dosed weekly
|
|
Experimental: Placebo and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
|
Drug: Placebo
Placebo - dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time
|
Detailed Description:
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
- Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
- The presence of a mass in the pancreas OR
- A history of resected pancreatic carcinoma
- Measurable disease per RECIST (ver. 1.1)
- ECOG Performance Status of 0 or 1.
- Adequate hepatic, hematologic and renal functions.
Exclusion Criteria:
- A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
- A diagnosis of pancreatic islet neoplasms.
- Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
- Presence of biliary obstruction requiring external drainage
- Brain metastases.
- Unstable cardiovascular function within the last 6 months of screening
- Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
- Known HIV infection.
- Uncontrolled hypertension at Screening
- History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
- 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.
- Uncontrolled systemic fungal, bacterial or viral infection
- Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472198
Show 58 Study Locations
Show 58 Study LocationsSponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Mike Hawkins, M.D. | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01472198 History of Changes |
| Other Study ID Numbers: | GS-US-324-0101 |
| Study First Received: | November 10, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
GS-6624 GSI Gilead Gilead Sciences Pancreatic Cancer PC |
Gemcitabine Phase 2 Phase II Oncology Monoclonal Antibody |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013