Solid TumorPhase 1NCT00718380

A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

A Phase 1 study testing ABT-869 in people with Solid Tumor, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Solid Tumor
What is being tested?: ABT-869
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: Sep 2008to Jun 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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
The subject must have adequate bone marrow, renal and hepatic function.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
The subject must voluntarily sign and date an informed consent.

Who cannot join

The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
The subject with the following conditions during screening assessment.
proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
a history of or currently exhibits clinically significant cancer related events of bleeding

Show all 11Show fewer

LV Ejection Fraction < 50%
received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
receiving therapeutic anticoagulation therapy
having fractures except for chronic bone lesion due to bone metastases
The subject exhibits evidence of other clinically significant uncontrolled condition(s).

About this study

Official title: An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors

Conditions: Solid Tumor
Being tested: ABT-869

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-869Drug
2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.

Study groups in NCT00718380
Study group	Role	What they receive
Group 1	Experimental	Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days Receives: Drug: ABT-869
Group 2	Experimental	Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1 Receives: Drug: ABT-869
Group 3	Experimental	Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2 Receives: Drug: ABT-869
Group 4	Experimental	Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3 Receives: Drug: ABT-869

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety tolerability assessment
Measured: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
Dose limiting toxicity determination
Measured: Weekly assessment for the first 3 weeks
Pharmacokinetic profile evaluation
Measured: Day 1 and Day 15

Secondary outcomes (1)

Preliminary tumor response
Measured: Every 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jun 2012

First posted18 Jul 2008 (estimated)
Study startSep 2008
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00718380
Sponsor's protocol ID: M10-227
Status last verified: Jul 2012
First submitted: 16 Jul 2008
Last updated: 21 Nov 2017
Results posted: No

Publications

Asahina H, Tamura Y, Nokihara H, Yamamoto N, Seki Y, Shibata T, Goto Y, Tanioka M, Yamada Y, Coates A, Chiu YL, Li X, Pradhan R, Ansell PJ, McKeegan EM, McKee MD, Carlson DM, Tamura T. An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2012 Jun;69(6):1477-86. doi: 10.1007/s00280-012-1846-6. Epub 2012 Mar 2.
PubMed 22382879

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
ClinicalTrials.gov ID: NCT00718380
Acronym / sponsor ID: M10-227
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 18 Jul 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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: ABT-869Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
Group 2	Experimental	Drug: ABT-869Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
Group 3	Experimental	Drug: ABT-869Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
Group 4	Experimental	Drug: ABT-869Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
The subject must have adequate bone marrow, renal and hepatic function.
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
The subject must voluntarily sign and date an informed consent.

Key exclusion criteria (11 listed)

The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
The subject with the following conditions during screening assessment.
The subject exhibits evidence of other clinically significant uncontrolled condition(s).

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-8692.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.	Drug	Group 1, Group 2, Group 3, Group 4

Primary outcome

Safety tolerability assessment
Time frame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
Dose limiting toxicity determination
Time frame: Weekly assessment for the first 3 weeks
Pharmacokinetic profile evaluation
Time frame: Day 1 and Day 15

1 secondary outcome

Preliminary tumor response
Time frame: Every 6 week

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 Nov 2017.
Results publication: PubMed 22382879Asahina H, Tamura Y, Nokihara H, Yamamoto N, Seki Y, Shibata T, Goto Y, Tanioka M, Yamada Y, Coates A, Chiu YL, Li X, Pradhan R, Ansell PJ, McKeegan EM, McKee MD, Carlson DM, Tamura T. An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2012 Jun;69(6):1477-86. doi: 10.1007/s00280-012-1846-6. Epub 2012 Mar 2.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
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.

Susumu Matsuki, BS study director

Abbott Japan Co.,Ltd

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-869 in people with Solid Tumor, run by AbbVie.

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 5 inclusion and 11 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 Nov 2017. 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 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?

Safety tolerability assessment (time frame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718380, which also lists 1 linked publication.

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 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.