A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Placebo to match simtuzumab; Drug: Simtuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01472198

GS-US-324-0101

Details and patient eligibility

About

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR

  2. 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 4 patient groups, including a placebo group

Simtuzumab (open-label)

Experimental group

Description:

Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Treatment:

Drug: Simtuzumab

Drug: Gemcitabine

Simtuzumab 200 mg (randomized)

Experimental group

Description:

Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Treatment:

Drug: Simtuzumab

Drug: Gemcitabine

Simtuzumab 700 mg (randomized)

Experimental group

Description:

Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Treatment:

Drug: Simtuzumab

Drug: Gemcitabine

Placebo (randomized)

Placebo Comparator group

Description:

Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.

Treatment:

Drug: Placebo to match simtuzumab

Drug: Gemcitabine