CancerPhase 1NCT00738764
A Trial of PDL192 in Subjects With Advanced Solid Tumors
A Phase 1 study testing PDL192 in people with Cancer, run by Abbott at 2 sites in United States.
Trial summary
This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PDL192
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Oct 2011
- 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
- Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Male or female, 18 years of age or older.
- Subjects with documented advanced solid tumors.
- Subjects who have previously failed all standard therapies or subjects who have a tumor where no standard therapy exists.
- A negative serum pregnancy test (women of childbearing potential only) at screening. Male or female subjects of reproductive potential must be willing to use adequate contraception during the duration of the study and for a minimum of 3 months after the end of treatment.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Who cannot join
- Subjects will be ineligible for this study if they meet any one of the following criteria:
- Symptomatic and progressive central nervous system (CNS) metastases or leptomeningeal metastases
- Diagnosis of glioblastoma
- Eastern Cooperative Oncology Group (ECOG) performance status >= 2
- Abnormal hematologic values defined as:
- Hemoglobin level < 9 g/dL
Show all 26Show fewer
- Absolute neutrophil count (ANC) < 1500/mm3
- Platelet count < 100,000/mm3
- Abnormal kidney, liver, or pancreatic function defined as:
- Serum creatinine > 1.5 x upper limit of normal value (ULN)
- Aspartate transaminase or alanine transaminase levels of > = 2.5 x ULN
- Bilirubin > ULN
- Amylase > 1.5 x ULN
- Lipase > 1.5 x ULN
- Known chronic viral hepatitis
- History of cirrhotic liver disease
- History of pancreatitis (patients with history of gall stone pancreatitis who are status post-cholecystectomy will be eligible)
- Acute cholecystitis within 6 months prior to the first dose of study drug
- Treatment with any investigational drug, antineoplastic agent, or antibodies within 21 days prior to the first dose of study drug (6 weeks for vaccines or nitrosureas)
- Proteinuria >1 g/24 hours (only subjects with > = 2+ with dipstick test will undergo 24 hour urine collection)
- Ongoing >= Grade 2 toxicities resulting from prior therapies
- Received continuous systemic steroids at doses greater than 10 mg/day of prednisone or its equivalent within 30 days prior to the first dose of study drug (intermittent dexamethasone given for prophylaxis or treatment of emesis is permitted)
- Received any immunosuppressive agent (except steroids) within 21 days prior to the first dose of study drug
- Known hypersensitivity to any component of the PDL192 formulation
- Uncontrolled medical problems such as diabetes mellitus, pancreatitis, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, or symptomatic heart failure
- Female subjects who are pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site Reference ID/Investigator# 53364
Aurora, Colorado, 80045
Site Reference ID/Investigator# 53365
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors
This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.
Read the detailed description
The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.
- Conditions
- Cancer
- Being tested
- PDL192
- Keywords
- cancer, antibody, Phase 1 Clinical Trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDL192Biological
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | PDL192 Dose Level 1 Receives: Biological: PDL192 |
| Cohort 2 | Experimental | PDL192 Dose Level 2 Receives: Biological: PDL192 |
| Cohort 3 | Experimental | PDL192 Dose Level 3 Receives: Biological: PDL192 |
| Cohort 4 | Experimental | PDL192 Dose Level 4 Receives: Biological: PDL192 |
| Cohort 5 | Experimental | PDL192 Dose Level 5 Receives: Biological: PDL192 |
| Cohort 6 | Experimental | PDL192 Dose Level 6 Receives: Biological: PDL192 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: after four weeks of dosing
Secondary outcomes (4)
The incidence and frequency of dose-limiting toxicities; The frequency, severity, and relationship of adverse events and serious adverse events;Incidence of abnormal findings in physical examinations and clinical laboratory values
Measured: during estimated average 4 month treatment period and 90 day follow up
Pharmacokinetic profile of PDL192 including maximum serum drug concentration, area under the concentration-time curve from time zero to infinity, systemic clearance, volume of distribution, and elimination half-life
Measured: during estimated average 4 month treatment period and 90 day follow up
Incidence of PDL192-specific antidrug antibodies
Measured: during estimated average 4 month treatment period and 90 day follow up
Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease)
Measured: during estimated average 4 month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, Abbott Biotherapeutics Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738764
- Sponsor's protocol ID
- PDL192-1801
- Status last verified
- Dec 2011
- First submitted
- 18 Aug 2008
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00738764
- Acronym / sponsor ID
- PDL192-1801
- Conditions
- Cancer
- Keywords
- cancer, antibody, Phase 1 Clinical Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Aug 2008 (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 a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.
Detailed description
The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: PDL192PDL192 Dose Level 1 |
| Cohort 2 | Experimental | Biological: PDL192PDL192 Dose Level 2 |
| Cohort 3 | Experimental | Biological: PDL192PDL192 Dose Level 3 |
| Cohort 4 | Experimental | Biological: PDL192PDL192 Dose Level 4 |
| Cohort 5 | Experimental | Biological: PDL192PDL192 Dose Level 5 |
| Cohort 6 | Experimental | Biological: PDL192PDL192 Dose Level 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Male or female, 18 years of age or older.
- Subjects with documented advanced solid tumors.
- Subjects who have previously failed all standard therapies or subjects who have a tumor where no standard therapy exists.
- A negative serum pregnancy test (women of childbearing potential only) at screening. Male or female subjects of reproductive potential must be willing to use adequate contraception during the duration of the study and for a minimum of 3 months after the end of treatment.
Key exclusion criteria (26 listed)
- Subjects will be ineligible for this study if they meet any one of the following criteria:
- Symptomatic and progressive central nervous system (CNS) metastases or leptomeningeal metastases
- Diagnosis of glioblastoma
- Eastern Cooperative Oncology Group (ECOG) performance status >= 2
- Abnormal hematologic values defined as:
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 |
|---|---|---|
| PDL192Humanized anti-TWEAK receptor monoclonal IgG1 antibody | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Maximum tolerated dose
Time frame: after four weeks of dosing
4 secondary outcomes
The incidence and frequency of dose-limiting toxicities; The frequency, severity, and relationship of adverse events and serious adverse events;Incidence of abnormal findings in physical examinations and clinical laboratory values
Time frame: during estimated average 4 month treatment period and 90 day follow up
Pharmacokinetic profile of PDL192 including maximum serum drug concentration, area under the concentration-time curve from time zero to infinity, systemic clearance, volume of distribution, and elimination half-life
Time frame: during estimated average 4 month treatment period and 90 day follow up
Incidence of PDL192-specific antidrug antibodies
Time frame: during estimated average 4 month treatment period and 90 day follow up
Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease)
Time frame: during estimated average 4 month treatment period
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 6 Jan 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.
Mihail Obrocea, MD study director
Abbott Biotherapeutics Corp.
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 PDL192 in people with Cancer, run by Abbott 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 6 inclusion and 26 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 6 Jan 2012. 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?
Maximum tolerated dose (time frame: after four weeks of dosing). 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 6 Jan 2012.