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Completed

NCT Number: NCT01472198

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan, Ufa, Bashkortostan Republic, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simtuzumab

Drug

Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Other names: GS-6624

Gemcitabine

Drug

Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle

Other names: Gemzar®

Placebo to match simtuzumab

Drug

Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Primary outcomes

  1. Progression free survival

    Time frame: Up to 3 years

    Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.

Secondary outcomes

  1. Overall survival

    Time frame: Up to 3 years

    Overall survival is measured as time from date of randomization to death regardless of cause.

  2. Objective response

    Time frame: Up to 3 years

    Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Nov 16, 2011
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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