Gastrointestinal CancerPhase 2NCT00089960
Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)
A Phase 2 study testing AMG 706 in people with Gastrointestinal Cancer, run by Amgen.
Trial summary
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- AMG 706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2008
- Phase
- Phase 2
- 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
- Age ≥ 18 years;
- Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
- Presence of at least one measurable (per RECIST)
- Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
- Karnofsky performance status ≥ 60;
- imatinib treatment terminated at least 7 days before study day 1;
- Adequate hepatic, renal, and cardiac function.
Who cannot join
- Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class > II),
- uncontrolled hypertension (systolic > 145 mmHg or diastolic > 85 mmHg),
- History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
- Absolute neutrophil count < 1.5x109/L, platelet count < 100x109/L, hemoglobin < 9.0 g/dL;
- Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
- The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.
About this study
Official title: An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
Read the detailed description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
- Conditions
- Gastrointestinal Cancer
- Being tested
- AMG 706
- Keywords
- GIST
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 706Drug
AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Other | AMG 125 mg daily continuously Receives: Drug: AMG 706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate as defined using modified RECIST criteria.
Measured: 48 weeks treatment or until progressive disease, or unacceptable toxicity
Secondary outcomes (12)
Progression-free survival
Measured: time from randomization to progressive disease
Overall survival
Measured: time to death
Time to progression
Measured: time from response to progressive disease
Time to response
Measured: time from first treatment to response
Patient-reported outcomes
Measured: quality of life
Use of opioid analgesics after minimal 6 months treatment
Measured: narcotics usage during study
Objective response by PET and tumor size/density changes at week 8
Measured: response rate at week 8
Objective response by size changes and/or target tumor density changes at week 8
Measured: response rate at week 8
Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related)
Measured: for duration of study
Duration of response
Measured: time to respone to progression
Palliative response
Measured: amelioration of symptoms
Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships
Measured: during specific study timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2004 (estimated)
- Study startOct 2004
- Primary completionJun 2006
- Study completionJun 2008
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 Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089960
- Sponsor's protocol ID
- 20040110
- Status last verified
- Apr 2013
- First submitted
- 18 Aug 2004
- Last updated
- 29 Apr 2013
- Results posted
- No
- Expanded access
- Available
Publications
Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.
PubMed 20838998
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
- ClinicalTrials.gov ID
- NCT00089960
- Acronym / sponsor ID
- 20040110
- Conditions
- Gastrointestinal Cancer
- Keywords
- GIST
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Aug 2004 (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 study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
Detailed description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | Other | Drug: AMG 706AMG 125 mg daily continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
- Presence of at least one measurable (per RECIST)
- Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
- Karnofsky performance status ≥ 60;
Key exclusion criteria (6 listed)
- Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class > II),
- uncontrolled hypertension (systolic > 145 mmHg or diastolic > 85 mmHg),
- History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
- Absolute neutrophil count < 1.5x109/L, platelet count < 100x109/L, hemoglobin < 9.0 g/dL;
- Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
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 |
|---|---|---|
| AMG 706AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity. | Drug | Arm |
Primary outcome
Objective response rate as defined using modified RECIST criteria.
Time frame: 48 weeks treatment or until progressive disease, or unacceptable toxicity
12 secondary outcomes
Progression-free survival
Time frame: time from randomization to progressive disease
Overall survival
Time frame: time to death
Time to progression
Time frame: time from response to progressive disease
Time to response
Time frame: time from first treatment to response
Patient-reported outcomes
Time frame: quality of life
Use of opioid analgesics after minimal 6 months treatment
Time frame: narcotics usage during study
Objective response by PET and tumor size/density changes at week 8
Time frame: response rate at week 8
Objective response by size changes and/or target tumor density changes at week 8
Time frame: response rate at week 8
Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related)
Time frame: for duration of study
Duration of response
Time frame: time to respone to progression
Palliative response
Time frame: amelioration of symptoms
Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships
Time frame: during specific study timepoints
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 29 Apr 2013.
- Results publication: PubMed 20838998Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 706 in people with Gastrointestinal Cancer, run by Amgen.
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 7 inclusion and 6 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 29 Apr 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Objective response rate as defined using modified RECIST criteria. (time frame: 48 weeks treatment or until progressive disease, or unacceptable toxicity). 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 NCT00089960, 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 29 Apr 2013.