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Advanced Solid TumorsPhase 1NCT00861419

To Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 386 When Used in Combination With AMG 706, Bevacizumab, Sorafenib, or Sunitinib.

A Phase 1 study testing Sorafenib, AMG 706 and AMG 386 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

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at least one dose level from each combination will be safe and well tolerated. 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?
Sorafenib, AMG 706 and AMG 386
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
Dec 2005to not given
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

  • Men or women at least 18 years old.
  • Subjects must have a pathologically documented, and definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for subjects who refuse standard therapy.
  • Subjects enrolling in arms E \& F and G \& H must have pathologically documented and definitively diagnosed advanced renal cell carcinoma.
  • Measurable disease or evaluable (non-measurable) disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
  • Eastern Cooperative Oncology Group (ECOG) performance status up to 2.
  • Subjects must be able to self-administer AMG 706 (arms B and D) or sorafenib (arms E and F) on an empty stomach (fasting for 1 hour before and 1 hour postdose) once daily for AMG 706 or twice daily for sorafenib. Subjects enrolling in arms G and H must be able to self-administer sunitinib once daily.

Who cannot join

  • History of lymphoma or leukemia.
  • Symptomatic or untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
  • Subjects with head and neck cancer.
  • Subjects with lung squamous cell tumors or with large central (located adjacent to or within the hilum or mediastinum) tumor lesions ≥ 3 centimeters, regardless of histology
  • For arms A and C: Subjects with ovarian cancer.
  • History of arterial or venous thrombosis or pulmonary embolism within 1 year before enrollment; history of bleeding diathesis.
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  • Cardiovascular events within 1 year before enrollment, such as myocardial infarction, unstable/severe angina, coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring medication, symptomatic congestive heart failure (New York Heart Association >class II), cerebrovascular accident or transient ischemic attack.
  • For arms G and H: LVEF ≤ 45%, heart rate < 50 / min.
  • Chronic uncontrolled hypertension [diastolic > 85 mmHg; systolic >145 mmHg].
  • History of pulmonary hemorrhage or gross hemoptysis within 6 months before enrollment.
  • History of significant GI surgery or disease, which would impair absorption.
  • Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia.
  • Active infection within 2 weeks before enrollment.
  • Subject known to have tested positive for HIV.
  • Subject known to have chronic hepatitis (e.g., hepatitis B or hepatitis C).
  • Coumarin anticoagulants including warfarin, at doses greater than 2 mg/day. The concurrent use of low molecular weight heparin or low dose warfarin (ie, ≤ 2 mg daily for prophylaxis against central venous catheter thrombosis is acceptable.
  • Treatment with anti-cancer therapy within 30 days before study day 1 (treatment with bevacizumab within 42 days before study day 1) unless prior written approval is received from the sponsor
  • Hormonal anti-tumor therapy within 30 days before enrollment. Does not include hormones for non-cancer related conditions (eg, insulin for diabetes, HRT) or the use of gonadotropin-releasing hormone (GnRH) agonists for prostate cancer
  • Therapeutic or palliative radiation therapy within 2 weeks before enrollment
  • Prior treatment with AMG 386
  • Prior radiation therapy to the abdomen
  • For arms A, B, C, and D: prior treatment with bevacizumab, sorafenib, sunitinib, or investigational agents known to directly inhibit the functions of vascular endothelial growth factor, vascular endothelial growth factor receptors, angiopoietins, or angiopoietin receptors, unless prior written approval is received from the sponsor
  • For arms E and F: prior treatment with sorafenib, unless prior written approval is received from the sponsor
  • For arms G and H: prior treatment with sunitinib, unless prior written approval is received from the sponsor
  • For arms E \& F and G \& H: treatment with bevacizumab within 42 days before study day 1, unless prior written approval is received from the sponsor
  • Major surgery within 30 days before enrollment or recovering from prior surgery
  • Subject who is pregnant or nursing

About this study

Official title: An Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 386 With AMG 706, AMG 386 With Bevacizumab, AMG 386 With Sorafenib, and AMG 386 With Sunitinib in Adult Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 386 when used in combination with AMG 706, bevacizumab, sorafenib, or sunitinib and that at least one dose level from each combination will be safe and well tolerated.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Being tested
Sorafenib, AMG 706, AMG 386, Sunitinib, Bevacizumab
Keywords
AMG 386, AMG 706, Bevacizumab, Sorafenib, Angiogenesis Inhibitors, Combination Therapy, Peptibody, Sunitinib

What participants receive

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

  • SorafenibDrug

    Also called Nexavar

    Sorafenib 400 mg PO (BID)

  • AMG 706Drug

    Also called Motesanib Diphosphate

    AMG 706 125 mg PO (QD)

  • AMG 706Drug

    Also called Motesanib Diphosphate

    AMG 706 75 mg PO (QD)

  • AMG 386Drug

    AMG 386 10 mg/kg IV (QW)

  • SunitinibDrug

    Also called Sutent

    Sunitinib 50 mg PO (QD)

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 15mg/kg IV Q3W

  • AMG 386Drug

    AMG 386 3 mg/kg IV (QW)

Study groups in NCT00861419
Study groupRoleWhat they receive
DExperimental3 mg/kg AMG 386 IV (QW) / 125 mg AMG 706 PO (QD)
Receives: Drug: AMG 706; Drug: AMG 386
AExperimental3 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
Receives: Drug: Bevacizumab; Drug: AMG 386
BExperimental3 mg/kg AMG 386 IV (QW) / 75 mg AMG 706 PO (QD)
Receives: Drug: AMG 706; Drug: AMG 386
EExperimental3 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)
Receives: Drug: Sorafenib; Drug: AMG 386
HExperimental10 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
Receives: Drug: AMG 386; Drug: Sunitinib
GExperimental3 mg/kg AMG 386 IV (QW) / 50 mg sunitinib PO (QD - 4 weeks on/2 weeks off)
Receives: Drug: Sunitinib; Drug: AMG 386
CExperimental10 mg/kg AMG 386 IV (QW) / 15 mg/kg bevacizumab IV (Q3W)
Receives: Drug: AMG 386; Drug: Bevacizumab
FExperimental10 mg/kg AMG 386 IV (QW) / 400 mg sorafenib PO (BID)
Receives: Drug: Sorafenib; Drug: AMG 386

What is being measured

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

  1. Safety including adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study. Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.

Secondary outcomes (1)

  1. Response based on biomarker, anti-AMG 386 antibody formation and tumor response measure by RECIST.

    Measured: End of Study

Timeline

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

  1. First posted13 Mar 2009 (estimated)
  2. Study startDec 2005

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00861419
Sponsor's protocol ID
20050170
Status last verified
Feb 2017
First submitted
12 Mar 2009
Last updated
8 Feb 2017
Results posted
No

Publications

  • Hong DS, Gordon MS, Samlowski WE, Kurzrock R, Tannir N, Friedland D, Mendelson DS, Vogelzang NJ, Rasmussen E, Wu BM, Bass MB, Zhong ZD, Friberg G, Appleman LJ. A phase I, open-label study of trebananib combined with sorafenib or sunitinib in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2014 Jun;12(3):167-177.e2. doi: 10.1016/j.clgc.2013.11.007. Epub 2013 Nov 13.

    PubMed 24365125

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sorafenib, AMG 706 and AMG 386 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 6 inclusion and 27 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 8 Feb 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 including adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study. Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.. 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 NCT00861419, 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 8 Feb 2017.

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