A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma

NCT00558207 | Completed Phase 2

• 1 other identifier: ARQ 197-205
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or gemcitabine. The study will also evaluate other efficacy and safety endpoints including overall response rate, overall survival and adverse events in the two treatment arms.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic cancer; pancreas cancer; Locally advanced or metastatic pancreatic adenocarcioma

Outcome Measures

Primary Outcomes (1)

• Evaluate progression-free survival (PFS) in patients receiving ARQ 197 versus gemcitabine.

  6 month

Secondary Outcomes (3)

• Evaluate overall response rate (ORR) in patients receiving ARQ 197 versus gemcitabine

  ongoing

• Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ197 versus gemcitabine

  6 and 12 month

• Further characterize the safety profile of ARQ 197

  ongoing

Study Arms (2)

1

EXPERIMENTAL

ARQ 197

Drug: ARQ 197

2

ACTIVE COMPARATOR

Gemcitabine

Drug: gemcitabine

Interventions

ARQ 197 DRUG

120 mg capsule administered twice daily for 240 mg total daily dose

1

gemcitabine DRUG

1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 4 weeks for the first 28 days (cycle). Each subsequent cycle will consist of 1000 mg/m2 administered as an intravenous infusion over 30 minutes once weekly for 3 weeks with no drug administered in the 4th week.

Also known as: Gemzar

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide signed and dated informed consent prior to study-specific screening procedures
• ≥ 18 years old
• Histologically or cytologically confirmed locally advanced or metastatic unresectable pancreatic adenocarcinoma
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
• Karnofsky performance status (KPS) ≥ 70%
• Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
• Females of childbearing potential must have a negative serum pregnancy test
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease
• Hemoglobin ≥ 10 g/dl
• Total bilirubin ≤ 1.5 × ULN
• Serum creatinine ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L

You may not qualify if:

• Received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational)
• Central nervous system metastases
• Pregnant or breastfeeding
• Significant gastrointestinal disorder, in the opinion of the Principal Investigator (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)
• Unable or unwilling to swallow ARQ 197 capsules twice daily
• Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
• Significant co-morbid conditions that in the opinion of the Investigator would impair study participation
• Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection

Sponsors & Collaborators

• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): lead

Study Sites (6)

Oddzial Kliniczny Kliniki Onkologii Szpital Uniwersytecki w Krakowie

Krakow, 31-531, Poland

Location

Oddzial Chemioterapii, Wojewodzki Szpital Specjalistyczny

Krakow, 31-826, Poland

Location

Oddział Onkologii Klinicznej, Regionalny Szpital Specjalistyczny "Latawiec"

Swidnica, 58-100, Poland

Location

Oddział Onkologii Klinicznej SP ZOZ Wojewódzki Szpital Zespolony im. L. Rydygiera

Torun, 53/59, Poland

Location

Klinika Onkologii WIM Warszawa

Warsaw, 00-909, Poland

Location

Oddział Chemioterapii Dolnośląskie Centrum Onkologii

Wroclaw, 53-413, Poland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

ARQ 197; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Cezary Szczylik, PhD

  Klinika Onkologii WIM

  PRINCIPAL INVESTIGATOR

• Janusz Pawlega, PhD

  Oddzial Kliniczny Kliniki Onkologii

  PRINCIPAL INVESTIGATOR

• Piotr Koralewski, MD

  Oddzial Chemioterapii Krakow

  PRINCIPAL INVESTIGATOR

• Emilia Filipczyk-Cisarz, MD

  Oddzial Chemioterapii Dolnoslaskie Centrum Onkologii

  PRINCIPAL INVESTIGATOR

• Ewa Kilar, MD

  Regionalny Szpital Specjalistyczny Latawiec

  PRINCIPAL INVESTIGATOR

• Piotr Sawrycki, MD

  Oddzial Onkologii Klinicznej im L Rydygiera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

PL (6)