Solid TumorsPhase 1NCT00754104
Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors
A Phase 1 study testing ABT-869 and Tarceva in people with Solid Tumors, run by Abbott.
Trial summary
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ABT-869 and Tarceva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
- Subject must have an ECOG Score of 0-2.
- Adequate organ function.
Who cannot join
- Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
- Subject has untreated brain or meningeal metastases.
- History of greater than 10% weight loss.
- Has clinically relevant hemoptysis.
- Subject has proteinuria CTC grade > 1.
- Must not have had radiation therapy or major surgery within 21 days of study day 1.
- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) > 100 mmHg or systolic blood pressure (SBP) > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
- The subject has a documented left ventricular ejection fraction (LVEF) < 50%.
About this study
Official title: A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors
- Conditions
- Solid Tumors
- Being tested
- ABT-869, Tarceva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-869Drug
0.25 mg/kg. daily.
TarcevaDrug
150mg, daily.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ABT-869; Drug: Tarceva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: Day 7, 15, 21, 35 and Day 1 of every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754104
- Sponsor's protocol ID
- M10-371
- Status last verified
- Jan 2009
- First submitted
- 15 Sep 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy
- ClinicalTrials.gov ID
- NCT00754104
- Acronym / sponsor ID
- M10-371
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 17 Sep 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.
Study of ABT-869 in Combination with Tarceva in Subjects with 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 |
|---|---|---|
| A | Experimental | Drug: ABT-869, Drug: Tarceva |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
- Subject must have an ECOG Score of 0-2.
- Adequate organ function.
Key exclusion criteria (8 listed)
- Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
- Subject has untreated brain or meningeal metastases.
- History of greater than 10% weight loss.
- Has clinically relevant hemoptysis.
- Subject has proteinuria CTC grade > 1.
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 |
|---|---|---|
| ABT-8690.25 mg/kg. daily. | Drug | A |
| Tarceva150mg, daily. | Drug | A |
Primary outcome
Pharmacokinetics
Time frame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks
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 19 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-869 and Tarceva in people with Solid Tumors, run by Abbott.
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 3 inclusion and 8 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 19 Jan 2011. 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?
Pharmacokinetics (time frame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks). 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 19 Jan 2011.