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Advanced Solid TumorsPhase 1NCT01386866

Single Dose Study of [14C]-Labelled AMG 706 in Patients With Advanced Solid Tumors

A Phase 1 study testing AMG 706 in people with Advanced Solid Tumors, run by Amgen.

Completed

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

Official record
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Trial summary

In order for a tumour to grow and spread to other parts of the body, it needs to have a blood supply. Certain proteins in the body, called cytokines or growth factors, have been shown to cause the growth of new blood vessels that supply tumours and therefore help the tumour to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
AMG 706
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
No sites listed yet
Study dates
May 2009to Dec 2010
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

  • Subjects with a pathologically documented and definitively diagnosed advanced solid tumor(excluding tumors that may significantly interfere with the absorption, metabolism, or excretion of the test article, such as primary or metastatic liver tumor with approximately >50% of liver tissue involvement) that is refractory to standard treatment or for which no curative therapy is available
  • Eastern Cooperative Oncology Group performance status of 0-1
  • Man or woman (male or female), age > 18 years
  • Ability to understand and sign an Independent Ethics Committee (IEC) Approved informed
  • Subjects must also fulfil Haematological, Renal, Hepatic and Coagulation criteria (not listed)

Who cannot join

  • Acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of Day 1
  • History of documented arterial or venous thrombosis within 1 year of Day 1
  • History of bleeding diathesis or bleeding within 14 days of Day 1, or hypercoagulopathy syndrome
  • History of life-threatening ventricular arrhythmia (e.g. sustained ventricular tachycardia)
  • History of pulmonary hemorrhage or gross hemoptysis (1/2 teaspoon of bright red blood or more) within 6 months of Day 1
  • Central nervous system metastases (exception: subjects with treated, asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before Day 1 are eligible)
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  • Subjects with non-small cell lung cancer (NSCLC)
  • Subjects with head and neck cancer
  • Subjects with ovarian cancer
  • Subjects with large central (located adjacent to or within the hilum or mediastinum) tumor lesions ≥ 3 cm, regardless of histology
  • Uncontrolled hypertension: average systolic blood pressure > 150 mm Hg or average diastolic blood pressure > 90 mm Hg (average blood pressure of the three separate blood pressure values measured within 10 minutes during screening)
  • Systemic chemotherapy within 28 days of Day 1
  • Radiotherapy within 28 days of Day 1 or within 14 days of Day 1 for peripheral lesions
  • Experimental or approved antibody therapy within 6 weeks before Day 1
  • Concurrent or prior (within 4 weeks prior to Day 1 of 5 half-lives of the medication which ever is longer) treatment with potent CYP3A inducers, including but not limited to : phenytoin, carbamazepine, rifampicin, phenobarbital and St John's Wort
  • Concurrent or prior (within 2 weeks prior to Day 1 or 5 half-lives of the medication which ever is longer) treatment with potent CYP3A inhibitors, including but not limited to: ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, cyclosporine, tacrolimus, nefazodone and/or HIV protease inhibitors
  • Concurrent or prior (within 2 weeks prior to Day 1) consumption of grapefruit (i.e. whole fruit or fruit juice)
  • Subjects who as a result of gastrointestinal surgeries (including cholecystectomy) or a medical condition (e.g. constipation, cholecystitis / cholelithiasis) that will significantly alter the absorption, metabolism or excretion of motesanib.
  • Subjects with irregular bowel habits (more than 3/day or less than 1 every 2 days).
  • Subjects who will not refrain from taking herbal/ complementary therapies (which have the potential to alter the absorption, metabolism, or excretion of the [14C]-AMG 706) for 7 days before first dosing, and for the duration of the ADME part of the study.
  • Concurrent immune modulators such as cyclosporine and tacrolimus
  • Any anti-coagulation therapy within 7 days prior to Day 1
  • Subjects whose occupation requires exposure to radiation or monitoring for radiation exposure
  • Clinically significant cardiac disease within 12 months of study Day 1, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication
  • Major surgery (that which requires general anesthesia) within 28 days or minor surgery within 14 days of Day 1
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
  • History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or investigational product administration or may interfere with the interpretation of the study results
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection or any co-morbid disease that would increase risk of toxicity
  • Any subject not consenting to use adequate contraceptive precautions (eg, hormonal, barrier or abstinence) during the course of the study and for 6 months after the last treatment
  • Female subjects who have a positive pregnancy test at screening or on Day-1
  • Female subjects who are breastfeeding or plan to breastfeed during the study or within 6 months after the last administration of the investigational product
  • Participation in a therapeutic clinical trial within 30 days of Day1
  • Subject is unwilling or unable to comply with the study requirements
  • Subject has a known sensitivity to any of the products to be administered over the course of the study (e.g. known hypersensitivity to study medication motesanib)
  • Subjects with a history of gall bladder and bile duct disease
  • Subjects with Gilberts syndrome

About this study

Official title: An Open-label, Single Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labelled AMG 706 (Motesanib) Followed by Extended Treatment With Motesanib in Patients With Advanced Solid Tumors

In order for a tumour to grow and spread to other parts of the body, it needs to have a blood supply. Certain proteins in the body, called cytokines or growth factors, have been shown to cause the growth of new blood vessels that supply tumours and therefore help the tumour to grow and spread. Motesanib (AMG 706) prevents these proteins from working, and may help to prevent the growth of tumours.

In the first part of this study, we will look at the way your body absorbs this drug into your blood, how your body changes and breaks down the drug, and then how the drug leaves your body in your urine and faeces.

In order to provide potential treatment benefit for the subjects who participated in the first part of the study, the second part of the study will allow subjects to continue on motesanib (AMG 706) treatment. The estimated length of this part of the study is unknown, and dependent on how subjects respond to motesanib (AMG 706).

Being tested
AMG 706
Keywords
AMG 706, Motesanib, Amgen, Phase 1

What participants receive

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

  • AMG 706Drug

    Single oral dose of 125 mg AMG 706 (motesanib) containing 100 μCi of [14C]-AMG 706 followed by option to continue onto a treatment extension phase for potential treatment benefit. Subjects will be administered motesanib 125 mg (5 x 25 mg tablets) on a daily basis until subjects experience a dose-limiting toxicity (DLT), an unacceptable AE, disease progression, or voluntary withdrawal.

Study groups in NCT01386866
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: AMG 706

What is being measured

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

  1. Profile and identification of metabolites of [14C]-AMG 706 in plasma, urine, and faeces

  2. Pharmacokinetics of total radioactivity in plasma and whole blood

  3. The mass balance of [14C]-AMG 706 (as the percentage of the dose administered) in urine and faeces

Secondary outcomes (2)

  1. • Measure the area under the plasma concentration curve versus time of AMG 706, as well as determine half-life and time of maximum concentration of AMG 706.

  2. The subject incidences of serious adverse events, adverse events, and clinically significant changes in vital signs and clinical laboratory tests

Timeline

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

  1. First posted1 Jul 2011 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2010
  4. Study completionDec 2010

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01386866
Sponsor's protocol ID
20080639
Status last verified
Jul 2011
First submitted
14 Apr 2011
Last updated
15 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 706 in people with Advanced 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 5 inclusion and 36 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 15 Jul 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?

Profile and identification of metabolites of [14C]-AMG 706 in plasma, urine, and faeces. 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 NCT01386866.

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 15 Jul 2011.

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