Pancreatic CancerPhase 2NCT00102700
ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
A Phase 2 study testing ARQ 501 in combination with gemcitabine in people with Pancreatic Cancer and Adenocarcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 15 sites in United States.
Trial summary
The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Adenocarcinoma
- What is being tested?
- ARQ 501 in combination with gemcitabine
- How many people
- 66 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
- Be treatment-naïve.
- Have measurable disease per RECIST Criteria.
- Be ≥18 years old.
- Have a Karnofsky Performance Status (KPS) of ≥70%.
- Have an estimated life expectancy of ≥12 weeks.
Show all 10Show fewer
- Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
- Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
- Sign a written informed consent form.
- Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.
Who cannot join
- Have 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).
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Have symptomatic or untreated central nervous system (CNS) metastases.
- Have a known hypersensitivity to gemcitabine.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jeffrey Meyerhardt
Boston, Massachusetts, 02115
University of Chicago Medical Center
Chicago, Illinois, 60637
Baylor College of Medicine
Houston, Texas, 77030
Moores UCSD Cancer Center
La Jolla, California, 92093
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Unversity of Kentucky Medical Center - Markey Center
Lexington, Kentucky, 40536
University of South Alabama
Mobile, Alabama, 36693
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
Virginia Cancer Institute
Richmond, Virginia, 23230
Scripps Cancer Center
San Diego, California, 92121
VA San Diego Healthcare System
San Diego, California, 92161
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
Read the detailed description
This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:
Primary Objective:
- Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.
Secondary Objectives:
- Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
- Further characterize the safety of ARQ 501 in combination with gemcitabine
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Being tested
- ARQ 501 in combination with gemcitabine
- Keywords
- cancer, solid tumor, advanced solid tumor, pancreas, pancreatic cancer, cancer of the pancreas
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 501 in combination with gemcitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Document progression free survival after treatment with ARQ 501 and gemcitabine
Secondary outcomes (1)
Document safety and efficacy of ARQ 501 in combination with gemcitabine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102700
- Sponsor's protocol ID
- ARQ 501-212
- Status last verified
- Apr 2009
- First submitted
- 1 Feb 2005
- Last updated
- 29 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00102700
- Acronym / sponsor ID
- ARQ 501-212
- Conditions
- Pancreatic Cancer, Adenocarcinoma
- Keywords
- cancer, solid tumor, advanced solid tumor, pancreas, pancreatic cancer, cancer of the pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
Detailed description
This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:
Primary Objective:
- Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.
Secondary Objectives:
- Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
- Further characterize the safety of ARQ 501 in combination with gemcitabine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
- Be treatment-naïve.
- Have measurable disease per RECIST Criteria.
- Be ≥18 years old.
- Have a Karnofsky Performance Status (KPS) of ≥70%.
Key exclusion criteria (7 listed)
- Have 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).
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Are pregnant or lactating.
- Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ 501 in combination with gemcitabine | Drug | – |
Primary outcome
Document progression free survival after treatment with ARQ 501 and gemcitabine
1 secondary outcome
Document safety and efficacy of ARQ 501 in combination with gemcitabine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ 501 in combination with gemcitabine in people with Pancreatic Cancer and Adenocarcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document progression free survival after treatment with ARQ 501 and gemcitabine. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.