MalignanciesPhase 1NCT00329329
Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies
A Phase 1 study testing satraplatin and capecitabine in people with Malignancies, run by Agennix at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancies
- What is being tested?
- satraplatin and capecitabine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Feb 2009
- 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
- Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
- Age > 18 years old
- ECOG Performance Status < 2
- Female patients may not be pregnant or lactating and must be willing to practice contraception
- Adequate organ function as defined by the following:
- Serum creatinine < 1.5 mg/dl
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- Absolute neutrophil count (ANC) > 1500/dL
- Platelets > 100,000/dL
- Total bilirubin < upper limit of normal (ULN) for the reference lab
- AST, ALT, and alkaline phosphatase must be within the designated range allowing for eligibility
Who cannot join
- Other chemotherapy treatment < 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent < 3 months from time of enrollment
- Radiotherapy involving > 30% of the active bone marrow
- Radiotherapy < 4 weeks prior to enrollment
- Pre-existing peripheral neuropathy > grade 1
- Pre-existing hearing loss > grade 2
- Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper
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- Patients who have not recovered (> grade 1) from the following toxicities of previous regimens before enrollment:
- hematologic toxicities
- fatigue
- mucositis
- nausea/vomiting
- diarrhea
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
- History of hypersensitivity reaction to capecitabine, 5-FU or any platinum containing drugs
- History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Evidence of concurrent second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ
- Concurrent use of medications that inhibit cytochrome P450 3A4 (including aprepitant)
- History of bone marrow or major organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Medical Center
Chicago, Illinois, 60611
About this study
Official title: Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.
Read the detailed description
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin in combination with capecitabine in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
- Conditions
- Malignancies
- Being tested
- satraplatin and capecitabine
- Keywords
- Advanced solid malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satraplatin and capecitabineDrug
satraplatin and capecitabine dose escalated per the dosing scheme
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Measured: 2007
Secondary outcomes (1)
Safety
Measured: 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2009
- Study completionFeb 2009
Why it stopped: Sponsor decided to discontinue study drug development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignanciesStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gradishar, MD, Principal investigator, Northwestern University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329329
- Sponsor's protocol ID
- SAT1-05-02
- Status last verified
- Mar 2012
- First submitted
- 22 May 2006
- Last updated
- 23 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00329329
- Acronym / sponsor ID
- SAT1-05-02
- Conditions
- Malignancies
- Keywords
- Advanced solid malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to discontinue study drug development
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AgennixIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 May 2006 (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 maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.
Detailed description
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin in combination with capecitabine in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
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)
- Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
- Age > 18 years old
- ECOG Performance Status < 2
- Female patients may not be pregnant or lactating and must be willing to practice contraception
- Adequate organ function as defined by the following:
Key exclusion criteria (19 listed)
- Other chemotherapy treatment < 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent < 3 months from time of enrollment
- Radiotherapy involving > 30% of the active bone marrow
- Radiotherapy < 4 weeks prior to enrollment
- Pre-existing peripheral neuropathy > grade 1
- Pre-existing hearing loss > grade 2
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 |
|---|---|---|
| satraplatin and capecitabinesatraplatin and capecitabine dose escalated per the dosing scheme | Drug | – |
Primary outcome
MTD
Time frame: 2007
1 secondary outcome
Safety
Time frame: 2007
Results and safety
The study was stopped early (reason given: Sponsor decided to discontinue study drug development). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
William Gradishar, MD principal investigator
Northwestern University Medical 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 satraplatin and capecitabine in people with Malignancies, run by Agennix 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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 23 Mar 2012. 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 was stopped early (reason given: Sponsor decided to discontinue study drug development). Results are not available in the source record.
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?
MTD (time frame: 2007). 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 23 Mar 2012.