Advanced Malignant Solid TumorsPhase 1NCT00997360
Study of PKI-179 Administered Orally to Subjects With Solid Tumors
A Phase 1 study testing PKI-179 in people with Advanced Malignant Solid Tumors, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- PKI-179
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2012
- 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
- Male or female subjects age 18 years or older.
- Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor. Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.
- Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides for exploratory biomarker analysis.
- Incurable cancer, with disease progression following at least 1 conventional, standard, or investigational therapy with no further standard treatment available in the opinion of the investigator.
- At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Eastern Cooperative Oncology Group (ECOG) 0 to 2.
- Acceptable laboratory values, including fasting serum glucose.
- All male and female subjects who are biologically capable of having children, must agree to use a medically acceptable method of birth control for the duration of the study (e.g., condom with a spermicide) and for 12 weeks after the last dose of investigational product. All female subjects who are biologically capable of having children must have a negative serum pregnancy test result before first dose of investigational product. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the active treatment phase of the study or for 12 weeks after the last dose of investigational product.
Who cannot join
- Major surgery, chemotherapy, radiotherapy, investigational therapy, or other cancer therapy within 2 weeks prior to first dose of investigational product.
- Lack of recovery from any prior surgery, chemotherapy, radiotherapy, or other cancer therapy.
- Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks before first dose of PKI-179 (no significant change in anticonvulsant doses, mental status, or clinical symptoms related to the CNS tumors).
- Subjects with known diabetes.
- QTc interval > 470 ms.
- Pregnant or breastfeeding women.
- Evidence of significant medical illness or abnormal laboratory finding that in the opinion of the investigator would substantially increase the risk associated with the subject's participation in the study or impact the assessment of safety and/or efficacy. Examples include, but are not limited to: uncontrolled seizures, serious ongoing active infection requiring treatment, significant uncontrolled cardiac disease, such as congestive heart failure, myocardial infarction within past 6 months, angina requiring treatment, or other clinically significant or uncontrolled conditions.
About this study
Official title: A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors
This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- PKI-179
- Keywords
- Phase 1, Maximum tolerated dose, Solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKI-179Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PKI-179 Receives: Drug: PKI-179 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events
Measured: 1 year
Secondary outcomes (1)
Tumor assessments, blood samples to look at how the drug enters your body and what the body does with it.
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 posted19 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997360
- Sponsor's protocol ID
- 3266A1-1002
- Status last verified
- Sep 2018
- First submitted
- 16 Oct 2009
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00997360
- Acronym / sponsor ID
- 3266A1-1002
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- Phase 1, Maximum tolerated dose, Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 19 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.
This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
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: PKI-179PKI-179 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects age 18 years or older.
- Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor. Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.
- Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides for exploratory biomarker analysis.
- Incurable cancer, with disease progression following at least 1 conventional, standard, or investigational therapy with no further standard treatment available in the opinion of the investigator.
- At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Key exclusion criteria (7 listed)
- Major surgery, chemotherapy, radiotherapy, investigational therapy, or other cancer therapy within 2 weeks prior to first dose of investigational product.
- Lack of recovery from any prior surgery, chemotherapy, radiotherapy, or other cancer therapy.
- Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks before first dose of PKI-179 (no significant change in anticonvulsant doses, mental status, or clinical symptoms related to the CNS tumors).
- Subjects with known diabetes.
- QTc interval > 470 ms.
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 |
|---|---|---|
| PKI-179 | Drug | 1 |
Primary outcome
Safety as measured by physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events
Time frame: 1 year
1 secondary outcome
Tumor assessments, blood samples to look at how the drug enters your body and what the body does with it.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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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 PKI-179 in people with Advanced Malignant Solid 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 8 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: withdrawn, as of the sponsor's last update on 27 Sep 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 physical examinations, electrocardiograms, laboratory assessments, vital signs, adverse events and serious adverse events (time frame: 1 year). 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 Sep 2018.