CarcinomaPhase 1NCT00099190
ARQ 501 in Combination With Docetaxel in Patients With Cancer
A Phase 1 study testing ARQ 501 in people with Carcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- ARQ 501
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Nov 2006
- Phase
- Phase 1
- 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 histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.)
- Be ≥18 years old.
- Must not be eligible for therapy of higher curative potential.
- Have a Karnofsky Performance Status (KPS) of ≥70%.
- Have an estimated life expectancy of ≥12 weeks.
- Be male or non-pregnant, non-lactating female patients. 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.
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- 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 document.
- Have adequate organ function as determined per protocol defined laboratory value
Who cannot join
- Have received previous treatment with ARQ 501.
- 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 received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
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- 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 severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Crowley Medical Research Center
Dallas, Texas, 75246
About this study
Official title: A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma
The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.
Read the detailed description
ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no histological cancer type studied appears inherently resistant to treatment with ARQ 501. In animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy, ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon.
This study is designed to explore whether the addition of ARQ 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.
- Conditions
- Carcinoma
- Being tested
- ARQ 501
- Keywords
- cancer, solid tumor, advanced solid tumor
- Medical subject headings
- Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 501Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of ARQ 501 in combination with docetaxel
Secondary outcomes (1)
Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2004 (estimated)
- Study startDec 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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)
- Investigators
- C. Casey Cunningham, MD, Principal investigator, Mary Crowley Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099190
- Sponsor's protocol ID
- ARQ 501-111
- Status last verified
- Apr 2009
- First submitted
- 10 Dec 2004
- Last updated
- 28 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma
- ClinicalTrials.gov ID
- NCT00099190
- Acronym / sponsor ID
- ARQ 501-111
- Conditions
- Carcinoma
- Keywords
- cancer, solid tumor, advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 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
- Dec 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 10 Dec 2004 (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 purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.
Detailed description
ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no histological cancer type studied appears inherently resistant to treatment with ARQ 501. In animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy, ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon.
This study is designed to explore whether the addition of ARQ 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.
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 (9 listed)
- Have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.)
- Be ≥18 years old.
- Must not be eligible for therapy of higher curative potential.
- Have a Karnofsky Performance Status (KPS) of ≥70%.
- Have an estimated life expectancy of ≥12 weeks.
Key exclusion criteria (9 listed)
- Have received previous treatment with ARQ 501.
- 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 received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in 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 | Drug | – |
Primary outcome
Determine the safety and tolerability of ARQ 501 in combination with docetaxel
1 secondary outcome
Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel
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 28 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.
C. Casey Cunningham, MD principal investigator
Mary Crowley Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARQ 501 in people with Carcinoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 1 site 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 9 inclusion and 9 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 28 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determine the safety and tolerability of ARQ 501 in combination with docetaxel. 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 28 Apr 2009.