TumorsPhase 1NCT01001936
Study Evaluating SKI-606 in Subject With Solid Tumors
A Phase 1 study testing SKI-606 in people with Tumors, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Tumors
- What is being tested?
- SKI-606
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2008
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
- Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Adequate hepatic, renal, and bone marrow function
- Age 20 to 74 years
- Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
- Life expectancy of at least 12 weeks
Who cannot join
- Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
- Prior exposure to SKI-606 or any other Src-kinase inhibitor
- Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
- Subjects unable or unwilling to swallow SKI-606 capsules
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
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- Recent or ongoing clinically-significant gastrointestinal disorder
- Pregnant or breastfeeding women
- Subjects who meet the following criteria:
- Evidence of serious active infection, significant medical or psychiatric illness
- History of unexplained syncope or known ventricular arrythmia
- Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
- Hypokalemia
- Unstable concurrent medical conditions
- Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study
About this study
Official title: Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors
- Conditions
- Tumors
- Being tested
- SKI-606
- Keywords
- PHASE 1 SKI-606 Solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKI-606Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SKI-606 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by AE information. Tolerability as measured by DLT observation.
Measured: 2 years
Secondary outcomes (1)
Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001936
- Sponsor's protocol ID
- 3160A1-102
- Status last verified
- Oct 2009
- First submitted
- 26 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT01001936
- Acronym / sponsor ID
- 3160A1-102
- Conditions
- Tumors
- Keywords
- PHASE 1 SKI-606 Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Oct 2009 (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 evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SKI-606 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
- Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Adequate hepatic, renal, and bone marrow function
- Age 20 to 74 years
Key exclusion criteria (15 listed)
- Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
- Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
- Prior exposure to SKI-606 or any other Src-kinase inhibitor
- Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
- Subjects unable or unwilling to swallow SKI-606 capsules
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 |
|---|---|---|
| SKI-606 | Drug | 1 |
Primary outcome
Safety as measured by AE information. Tolerability as measured by DLT observation.
Time frame: 2 years
1 secondary outcome
Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST
Time frame: 2 years
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 27 Oct 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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKI-606 in people with Tumors, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 7 inclusion and 15 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 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety as measured by AE information. Tolerability as measured by DLT observation. (time frame: 2 years). 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 27 Oct 2009; AzTrials last refreshed its copy on 26 Oct 2026.