AzTrials
AzTrials

Advanced Solid TumorsPhase 1NCT00785941

A Study of IMC-A12 Every 2 Weeks in Patients With Tumors Who No Longer Respond to Treatment or No Treatment is Available

A Phase 1 study testing IMC-A12 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients. 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?
IMC-A12
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Apr 2006to Nov 2007
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

  • Patients with histopathologically-documented, measurable, advanced primary or recurrent solid tumors who no longer respond to standard therapy or for whom no standard therapy is available
  • A life expectancy of >3 months
  • Adequate hematologic function
  • Adequate hepatic function
  • Adequate renal function
  • Use of effective contraception, if procreative potential exists.
Show all 9Show fewer
  • At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, prior radiation therapy (palliative radiation therapy is allowed), an open biopsy, or a significant traumatic injury to allow for adequate recovery
  • At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal antibody therapy to allow for adequate recovery
  • Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center

Who cannot join

  • Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥3 years will be allowed to enter the trial
  • Uncontrolled intercurrent illness including, but not limited to:
  • ongoing or active infection requiring parenteral antibiotics
  • symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)
  • unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • uncontrolled hypertension (systolic blood pressure >160 mm Hg, diastolic blood pressure >100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
Show all 19Show fewer
  • clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute {NCI}-Common Terminology Criteria for Adverse Events {CTCAE}, Version 3.0, grade 3] or asymptomatic sustained ventricular tachycardia)
  • psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
  • patients with symptomatic brain metastases (patients with a history of brain metastases must be clinically stable and not taking steroids; anticonvulsants are allowed)
  • A serious or nonhealing active wound, ulcer, or bone fracture
  • Known human immunodeficiency virus-positive
  • A history of a hemorrhagic or thrombotic disorder within 9 months
  • Pregnant or breast feeding
  • A history of prior treatment with other agents specifically targeting IGFRs.
  • Known diabetes
  • Inability or unwillingness to interrupt steroidal or hormonal therapy for the duration of treatment with IMC-A12
  • A positive anti-IMC-A12 antibody response
  • A history of allergic reactions to monoclonal antibodies or other therapeutic proteins
  • Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ImClone Investigational Site

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 Administered Every Other Week in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available

The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients.

Read the detailed description

The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered every other week in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

Being tested
IMC-A12
Keywords
Tumors, Antibodies, Monoclonal
Medical subject headings
Neoplasms

What participants receive

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

  • IMC-A12Biological

    Also called Cixutumumab

    Cohort 1

    6 mg/kg I.V., once every other week for 4 weeks

  • IMC-A12Biological

    Also called Cixutumumab

    Cohort 2

    10 mg/kg I.V., once every other week for 4 weeks

  • IMC-A12Biological

    Also called Cixutumumab

    Cohort 3

    15 mg/kg I.V., once every other week for 4 weeks

  • IMC-A12Biological

    Also called Cixutumumab

    Cohort 4

    21 mg/kg I.V., once every other week for 4 weeks

  • IMC-A12Biological

    Also called Cixutumumab

    Cohort 5

    27 mg/kg I.V., once every other week for 4 weeks

Study groups in NCT00785941
Study groupRoleWhat they receive
IMC-A12ExperimentalAll patients will receive intravenous infusions of IMC-A12, with the dose depending on which cohort they are enrolled into a minimum of three patients will be enrolled in each Cohort. When all patients complete a cohort, dose escalation to the next Cohort will occur. A treatment cycle will consist of IMC-A12 administered intravenously, once every other week for 4 weeks, for a total of 2 doses; followed by a 2-week observation period.
Receives: Biological: IMC-A12

What is being measured

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

  1. Number of participants with Adverse Events (AEs)

    Measured: 8 weeks

  2. Maximum Tolerated Dose

    Measured: 8 weeks

Secondary outcomes (8)

  1. Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  2. Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  3. Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  4. Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  5. Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  6. Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5

    Measured: 8 weeks

  7. Serum Anti-IMC-A12 Antibody Assessment (immunogenicity)

    Measured: 8 weeks

  8. Change in tumor size from Baseline Measurement

    Measured: 8 weeks

Timeline

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

  1. First posted5 Nov 2008 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2007
  4. Study completionNov 2007

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785941
Sponsor's protocol ID
13933
Other IDs
CP13-0502, I5A-IE-JAEI
Status last verified
Oct 2011
First submitted
4 Nov 2008
Last updated
13 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Higano CS, Berlin J, Gordon M, LoRusso P, Tang S, Dontabhaktuni A, Schwartz JD, Cosaert J, Mehnert JM. Safety, tolerability, and pharmacokinetics of single and multiple doses of intravenous cixutumumab (IMC-A12), an inhibitor of the insulin-like growth factor-I receptor, administered weekly or every 2 weeks in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):450-62. doi: 10.1007/s10637-015-0217-7. Epub 2015 Mar 7.

    PubMed 25749986

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMC-A12 in people with Advanced Solid Tumors, run by Eli Lilly and Company at 1 site 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 9 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 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Number of participants with Adverse Events (AEs) (time frame: 8 weeks). 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 NCT00785941, 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 13 Oct 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in