Advanced/Metastatic Solid TumorsPhase 1NCT00996255
Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing PHA-793887 in people with Advanced/Metastatic Solid Tumors, run by Nerviano Medical Sciences at 2 sites in 2 countries.
Trial summary
The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- PHA-793887
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2006to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced/metastatic solid tumors for which no standard therapy exists
- ECOG (WHO) performance status 0-1
- Life expectancy of at least 3 months
- Age ≥ 18 years
- Adequate liver, pancreas and renal function
- Acceptable hematologic status
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- Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1
- Treatment with surgery, chemotherapy, or investigational therapy must be completed at least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin C and liposomal doxorubicin)
- Prior radiation therapy allowed in no more than 25% of bone marrow reserve
- Men and women of child-producing potential must agree upon the use of effective contraceptive methods
Who cannot join
- In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- Known brain metastases
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or breast feeding women
- Known infection with HIV, active hepatitis B or hepatitis C
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- Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation
- History of pancreatitis or disorders making the patient at risk of pancreatitis
- Previous history or current presence of neurological disorders
- Patients with pre-existing symptoms of peripheral neuropathy not related to prior anticancer therapy(ies)
- Concomitant treatment that may be associated with peripheral neuropathy
- Other severe concurrent conditions that could compromise protocol objectives.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors
The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- PHA-793887
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHA-793887Drug
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation | Experimental | Not described Receives: Drug: PHA-793887 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose
Measured: First cycle
Secondary outcomes (3)
Assessment of Adverse Events (based on CTCAE version 3.0)
Measured: All cycles
Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.
Measured: First 2 cycles
Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.
Measured: First cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Charles Soria, MD Professor, Principal investigator, Institut Gustave-Roussy, Villejuif Cedex, FranceChris Twelves, MD Professor, Principal investigator, St James University Hospital, Leeds, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996255
- Sponsor's protocol ID
- CDKC-887-001
- Other IDs
- EudraCT Number: 2006-002149-35
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00996255
- Acronym / sponsor ID
- CDKC-887-001
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 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 open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation | Experimental | Drug: PHA-793887 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced/metastatic solid tumors for which no standard therapy exists
- ECOG (WHO) performance status 0-1
- Life expectancy of at least 3 months
- Age ≥ 18 years
- Adequate liver, pancreas and renal function
Key exclusion criteria (12 listed)
- In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- Known brain metastases
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Pregnant or breast feeding women
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 |
|---|---|---|
| PHA-793887Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles. | Drug | Dose-Escalation |
Primary outcome
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose
Time frame: First cycle
3 secondary outcomes
Assessment of Adverse Events (based on CTCAE version 3.0)
Time frame: All cycles
Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.
Time frame: First 2 cycles
Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.
Time frame: First cycle
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
Jean-Charles Soria, MD Professor principal investigator
Institut Gustave-Roussy, Villejuif Cedex, France
Chris Twelves, MD Professor principal investigator
St James University Hospital, Leeds, UK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PHA-793887 in people with Advanced/Metastatic Solid Tumors, run by Nerviano Medical Sciences at 2 sites in 2 countries.
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 12 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 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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. 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?
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose (time frame: First cycle). 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 16 Oct 2009.