Solid TumorsPhase 1NCT00448786
Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors
A Phase 1 study testing AMG 706 in people with Solid Tumors, run by Amgen.
Trial summary
The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. 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?
- AMG 706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 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
- Histologically confirmed advanced metastatic solid tumor
- Ineligible to receive or progressed on standard of care therapies
- Measurable or non-measurable disease per modified RECIST
- Gallbladder must be in situ on screening ultrasound
- ECOG Performance Status of 0 to 2
- Life expectancy of 6 months or more as determined by the investigator
- Adequate organ and hematologic function as evidenced by laboratory studies prior to randomization
- Men and women 18 years or older
Who cannot join
- Uncontrolled CNS metastases
- Known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease
- Radiation therapy within 14 days prior to randomization
- Peripheral neuropathy > Grade 1 per CTC AE v.3
- Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248 (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib)
- Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from the last dose of bevacizumab to the date of randomization
Show all 19Show fewer
- Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and warfarin for prophylaxis against central venous catheter thrombosis is allowed
- Less than 30 days have elapsed since participation in an investigational drug/device study or currently receiving investigational treatments
- History of arterial or venous thrombosis within 1 year prior to randomization
- History of bleeding diathesis or bleeding within 14 days of randomization
- MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or unstable angina within one year prior to randomization
- Uncontrolled HTN defined by a resting BP of >150/90 mmHg
- Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization; minor surgical procedure, placement of access device or fine needle aspiration within 7 days of randomization; planned elective surgery while on study
- Non-healing or open wound, ulcer or fracture
- Known ongoing or active infection
- Known (+) for HIV, Hep C or Hep B surface antigen
- Known chronic hepatitis
- Known history of allergy or hypersensitivity to AMG 706 or any of its components
- Pregnant, ie, (+) b-HCG; breastfeeding
About this study
Official title: An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors
The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.
- Conditions
- Solid Tumors
- Being tested
- AMG 706
- Keywords
- gallbladder, AMG 706, solid tumors, Phase 1b, Amgen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 706Drug
Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
AMG 706Drug
Arm C - 75 mg BID 5-days on, 2-days off
AMG 706Drug
AMG 706 125 mg daily continuously (Arm A)
| Study group | Role | What they receive |
|---|---|---|
| Arm C | Other | Arm C - AMG 706 75 mg BID 5-days on and 2-days off Receives: Drug: AMG 706 |
| Arm B | Other | Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off Receives: Drug: AMG 706 |
| Arm A | Other | Arm A = AMG 706 125 mg PO daily continuously Receives: Drug: AMG 706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in gallbladder size (volume by ultrasound)
Measured: Anticipated 8 months of treatment with AMG 706
Average change from baseline in gallbladder function (ejection fraction)
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Secondary outcomes (7)
Average changes from baseline in gallbladder size (volume by CT scan)
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Objective response in subjects with measurable disease at baseline
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Pharmacokinetics of AMG 706 monotherapy
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge
Measured: Subject treatment with AMG 706 anticipated to be 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionMar 2009
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 TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448786
- Sponsor's protocol ID
- 20060443
- Status last verified
- Jan 2011
- First submitted
- 15 Mar 2007
- Last updated
- 21 Jan 2011
- Results posted
- No
Publications
Rosen LS, Lipton L, Price TJ, Belman ND, Boccia RV, Hurwitz HI, Stephenson JJ Jr, Wirth LJ, McCoy S, Hei YJ, Hsu CP, Tebbutt NC. The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors. BMC Cancer. 2013 May 16;13:242. doi: 10.1186/1471-2407-13-242.
PubMed 23679351
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00448786
- Acronym / sponsor ID
- 20060443
- Conditions
- Solid Tumors
- Keywords
- gallbladder, AMG 706, solid tumors, Phase 1b, Amgen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Mar 2007 (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 study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm C | Other | Drug: AMG 706Arm C - AMG 706 75 mg BID 5-days on and 2-days off |
| Arm B | Other | Drug: AMG 706Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off |
| Arm A | Other | Drug: AMG 706Arm A = AMG 706 125 mg PO daily continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed advanced metastatic solid tumor
- Ineligible to receive or progressed on standard of care therapies
- Measurable or non-measurable disease per modified RECIST
- Gallbladder must be in situ on screening ultrasound
- ECOG Performance Status of 0 to 2
Key exclusion criteria (19 listed)
- Uncontrolled CNS metastases
- Known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease
- Radiation therapy within 14 days prior to randomization
- Peripheral neuropathy > Grade 1 per CTC AE v.3
- Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248 (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib)
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 706Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off | Drug | Arm B |
| AMG 706Arm C - 75 mg BID 5-days on, 2-days off | Drug | Arm C |
| AMG 706AMG 706 125 mg daily continuously (Arm A) | Drug | Arm A |
Primary outcome
Average change from baseline in gallbladder size (volume by ultrasound)
Time frame: Anticipated 8 months of treatment with AMG 706
Average change from baseline in gallbladder function (ejection fraction)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
7 secondary outcomes
Average changes from baseline in gallbladder size (volume by CT scan)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Objective response in subjects with measurable disease at baseline
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Pharmacokinetics of AMG 706 monotherapy
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
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 Jan 2011.
- Derived from this study: PubMed 23679351Rosen LS, Lipton L, Price TJ, Belman ND, Boccia RV, Hurwitz HI, Stephenson JJ Jr, Wirth LJ, McCoy S, Hei YJ, Hsu CP, Tebbutt NC. The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors. BMC Cancer. 2013 May 16;13:242. doi: 10.1186/1471-2407-13-242.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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 1 study testing AMG 706 in people with Solid Tumors, 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 8 inclusion and 19 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 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 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?
Average change from baseline in gallbladder size (volume by ultrasound) (time frame: Anticipated 8 months of treatment with AMG 706). The study lists 2 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 NCT00448786, 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 Jan 2011.