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Advanced Solid TumorsPhase 1NCT01331941

A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function

A Phase 1 study testing AMG 386 + Paclitaxel and AMG 386 in people with Advanced Solid Tumors and Kidney Disease, run by Amgen at 4 sites in United States.

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

This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of AMG 386 intravenously. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMG 386 + Paclitaxel and AMG 386
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
4 sitesUnited States
Study dates
19 Sep 2011to 26 Feb 2013
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 ≥ 18 years of age
  • Must have a pathologically documented, and definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
  • Evaluable OR measurable disease by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Life expectancy of > 3 months, in the opinion of and as documented by the investigator
  • Subject or subject's legally acceptable representative has provided informed consent

Who cannot join

  • Subjects with gastric cancer or any malignancy with purely squamous cell histology
  • Known history of primary central nervous system (CNS) tumors or CNS metastases
  • Myocardial infarction within 1 year before study day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association > class II, uncontrolled hypertension [diastolic > 90 mmHg; systolic > 150 mmHg in repeated measurements])
  • History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study day 1
  • Active grade 2 or greater peripheral vascular disease or peripheral edema
  • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
Show all 19Show fewer
  • Non-healing wound, ulcer (including gastrointestinal) or fracture
  • Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection
  • Major surgery within 4 weeks before study day 1
  • Absolute neutrophils count (ANC) < 1.0 x 10^9/L; or platelet count < 100 x 10^9/L; or hemoglobin < 9 g/dL; or PTT / aPTT > 1.5 x institutional upper limit of normal (ULN) ); or INR > 1.5
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN (> 5.0 x ULN if liver metastases present)
  • Alkaline phosphatase > 2.5 x ULN (> 5.0 x ULN if attributable to liver or bone metastasis)
  • Total bilirubin > 1.5 x ULN
  • Other investigational procedures during the study
  • Previous anti-cancer therapy or investigational agent within 4 weeks prior to study day 1
  • Anticoagulation therapy within 4 weeks of study day 1 and while on study (except low dose warfarin (≤ 2 mg/kg) for prophylaxis against central venous catheter thrombosis)
  • Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or IUD (women).
  • Women who are lactating/breastfeeding.
  • Women with a positive pregnancy test.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Research Site

    Atlanta, Georgia, 30332

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Cleveland, Ohio, 44106

  • Research Site

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: An Open-label Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects With Normal and Impaired Renal Function

This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5 weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.

Being tested
AMG 386 + Paclitaxel, AMG 386
Keywords
AMG 386, Pharmacokinetic, Renal Impairment
Medical subject headings
Kidney Diseases, Renal Insufficiency

What participants receive

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

  • AMG 386 + PaclitaxelDrug

    15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.

  • AMG 386Drug

    15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.

Study groups in NCT01331941
Study groupRoleWhat they receive
Group 1ExperimentalCancer subjects with normal renal function.
Receives: Drug: AMG 386 + Paclitaxel; Drug: AMG 386
Group 3ExperimentalCancer subjects with moderate renal impairment.
Receives: Drug: AMG 386 + Paclitaxel; Drug: AMG 386
Group 4ExperimentalCancer subjects with severe renal impairment.
Receives: Drug: AMG 386
Group 2ExperimentalCancer subjects with mild renal impairment.
Receives: Drug: AMG 386 + Paclitaxel; Drug: AMG 386

What is being measured

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

  1. Area under the serum concentration-time curve (AUC)

    Measured: Week 1-5.

  2. Maximum observed concentration (Cmax)

    Measured: Week 1-5.

  3. Time to maximum concentration (tmax)

    Measured: Week 1-5.

  4. Minimum observed concentration (Cmin)

    Measured: Week 1-5.

  5. Clearance (CL) of AMG 386 calculated as dose divided by AUC on week 5.

    Measured: Week 1-5

Secondary outcomes (5)

  1. Adverse events as a measure of safety

    Measured: Weekly at each visit AMG 386 is administered, on day 30, 31 and 32 when only PK assessments are scheduled up to and including the last study visit 30 days after the last AMG 386 administration.

  2. Changes in vital signs as a measure of safety

    Measured: Weekly at each visit AMG 386 is administered up to and including the last study visit 30 days after the last AMG 386 administration.

  3. Changes in clinical laboratory tests as a measure of safety

    Measured: Weekly from week 1-9 then every 4 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.

  4. Anti-AMG 386 antibody formation

    Measured: Week 1, week 5, week 9 and every 16 weeks thereafter including the last study visit 30 days after the last AMG 386 administration.

  5. Tumor objective response measured by CT or MRI (without Gadolinium contrast agents) and assessed by RECIST 1.1 criteria.

    Measured: Week 5 and every 8 weeks thereafter until the subject's end of participation in the study.

Timeline

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

  1. First posted8 Apr 2011 (estimated)
  2. Study start19 Sep 2011
  3. Primary completion26 Feb 2013

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331941
Sponsor's protocol ID
20090277
Status last verified
Nov 2017
First submitted
24 Mar 2011
Last updated
6 Nov 2017
Results posted
No

Publications

  • Wu B, Lewis LD, Harvey RD, Rasmussen E, Gamelin E, Sun YN, Friberg G, Koyner JL, Dowlati A, Maitland ML. A Pharmacokinetic and Safety Study of Trebananib, an Fc-Fusion Peptibody, in Patients With Advanced Solid Tumors and Varying Degrees of Renal Dysfunction. Clin Pharmacol Ther. 2017 Aug;102(2):313-320. doi: 10.1002/cpt.617. Epub 2017 Jun 9.

    PubMed 28074547

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 386 + Paclitaxel and AMG 386 in people with Advanced Solid Tumors and Kidney Disease, run by Amgen at 4 sites in United States.

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 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Area under the serum concentration-time curve (AUC) (time frame: Week 1-5.). The study lists 5 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 NCT01331941, 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 6 Nov 2017.

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