Solid TumourPhase 1NCT01300468
Study of PHA-848125AC in Adult Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing PHA-848125AC in people with Solid Tumour, run by Nerviano Medical Sciences at 2 sites in United States.
Trial summary
The purpose of this open-label, multi center, Phase I study was to determine the safety profile of the oral compound PHA-848125AC administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumour
- What is being tested?
- PHA-848125AC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Dec 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
- Signed, written IRB-approved Informed Consent
- Histologically or cytologically confirmed relapsed or refractory solid tumors for which no standard therapy exists
- ECOG (WHO) performance status 0-1
- Life expectancy of at least 3 months
- Age >=18 years
- A negative pregnancy test (if female in reproductive years)
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- Acceptable liver and renal function
- Acceptable hematologic status
- 10. Previous cancer therapy is allowed with the exclusion of experimental CDK2 inhibitors. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy must be completed within one month prior to study entry
- Use of effective contraceptive methods if men and women of child producing potential
- Capability to swallow capsules intact
- Grade <=1 retinopathy
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
- Unwillingness or inability to comply with procedures required in this protocol
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- Known infection with HIV, active hepatitis B or hepatitis C
- Diabetes mellitus uncontrolled, or with clinical evidence of diabetic retinopathy, severe peripheral vascular disease or diabetic ulcers
- Current enrollment in another clinical trial
- Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (lactose intolerance)
- Previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease, multiple sclerosis, stroke and cerebellar injury
- Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption
- Chronic/intensive use of antacid or H2 receptor antagonists
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Johns Hopkins University
Baltiomore, Maryland, 21212
Scottsdale Clinical Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase I Study of Oral PHA-848125AC Given Daily For 7 Consecutive Days Every 2 Weeks or for 4 Consecutive Days A Week for 3 Consecutive Weeks Every 4 Weeks to Adult Patients With Advanced/Metastatic Solid Tumors
The purpose of this open-label, multi center, Phase I study was to determine the safety profile of the oral compound PHA-848125AC administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. Objectives of the study were to determine the maximum tolerated dose and the dose that can be recommended for Phase II investigations.
- Conditions
- Solid Tumour
- Being tested
- PHA-848125AC
- Keywords
- advanced/metastatic solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHA-848125ACDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation | Experimental | Not described Receives: Drug: PHA-848125AC |
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 (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startApr 2006
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumourStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Von Hoff, MD, Principal investigator, Scottsdale Clinical Research Institute, Scottsdale AZ, USAManuel Hidalgo, MD, Principal investigator, The Johns Hopkins University, Baltimore MD, USADaniel Laheru, MD, Principal investigator, The Johns Hopkins University, Baltimore MD, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300468
- Sponsor's protocol ID
- CDKO-125a-001
- Status last verified
- Feb 2011
- First submitted
- 17 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oral PHA-848125AC Given Daily For 7 Consecutive Days Every 2 Weeks or for 4 Consecutive Days A Week for 3 Consecutive Weeks Every 4 Weeks to Adult Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01300468
- Acronym / sponsor ID
- CDKO-125a-001
- Conditions
- Solid Tumour
- Keywords
- advanced/metastatic solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Feb 2011 (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 the oral compound PHA-848125AC administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. Objectives of the study were to determine the maximum tolerated dose and the dose that can be recommended for 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-848125AC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed, written IRB-approved Informed Consent
- Histologically or cytologically confirmed relapsed or refractory solid tumors for which no standard therapy exists
- ECOG (WHO) performance status 0-1
- Life expectancy of at least 3 months
- Age >=18 years
Key exclusion criteria (14 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-848125AC | Drug | Dose-escalation |
Primary outcome
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose
Time frame: First cycle
2 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
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 21 Feb 2011.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Daniel Von Hoff, MD principal investigator
Scottsdale Clinical Research Institute, Scottsdale AZ, USA
Manuel Hidalgo, MD principal investigator
The Johns Hopkins University, Baltimore MD, USA
Daniel Laheru, MD principal investigator
The Johns Hopkins University, Baltimore MD, USA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PHA-848125AC in people with Solid Tumour, run by Nerviano Medical Sciences at 2 sites 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 12 inclusion and 14 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 21 Feb 2011. 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 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?
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 21 Feb 2011.