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CarcinomaPhase 2NCT00781911

A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

A Phase 2 study testing Cixutumumab and depot octreotide in people with Carcinoma and Neuroendocrine Tumors, run by Eli Lilly and Company at 10 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

Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Neuroendocrine Tumors
What is being tested?
Cixutumumab and depot octreotide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
10 sitesUnited States
Study dates
Feb 2009to May 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors
  • The participant has metastatic disease at the time of study entry
  • The participant must have a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, 24-hour urine 5-HIAA, chromogranin A, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both
  • The participant is age ≥ 18 years
  • The participant's tumor has Ki-67 expression ≤ 20%
  • The participant is receiving depot octreotide therapy at the time of enrolling into the study
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  • The participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments
  • The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy
  • The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide
  • The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible
  • The participant has a life expectancy of > 3 months
  • The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
  • The participant has adequate hematologic function as defined by absolute neutrophil count ≥ 1500/microliters (μL), hemoglobin ≥ 9 gram/deciliter (g/dL), and platelet count ≥100,000/μL
  • The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x the ULN (or ≤ 5 x the ULN in the presence of known liver metastases)
  • The participant either has adequate coagulation function as defined by international normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN, or is on a stable dose of anticoagulant
  • The participant has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN or creatinine clearance ≥ 60 milliliter/minute (mL/min) for participants with creatinine levels above the ULN
  • The participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)≤ 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not required
  • Because the teratogenicity of cixutumumab is not known, women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • The participant has the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • The participant has uncontrolled brain or leptomeningeal metastases
  • The participant has not recovered to Grade ≤ 1 from adverse events due to agents administered more than 4 weeks prior to study entry (except for alopecia)
  • The participant is receiving any other investigational agent(s)
  • The participant has received therapeutic radiolabeled somatostatin analogues
  • The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting
  • The participant has a history of treatment with other agents targeting the IGF receptor
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  • The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of cixutumumab or to octreotide
  • The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their fasting glucose < 160 mg/dL or below the ULN and that they are on a stable dietary or therapeutic regimen for this condition
  • The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • The participant is pregnant or lactating
  • The participant is known to be positive for infection with the human immunodeficiency virus
  • The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last 3 years

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • ImClone Investigational Site

    Atlanta, Georgia, 30318

  • ImClone Investigational Site

    Aurora, Colorado, 80045

  • ImClone Investigational Site

    Columbus, Ohio, 43210

  • ImClone Investigational Site

    Dallas, Texas, 75246

  • ImClone Investigational Site

    Indianapolis, Indiana, 46202

  • ImClone Investigational Site

    Kenner, Louisiana, 70065

  • ImClone Investigational Site

    Los Angeles, California, 90033

  • ImClone Investigational Site

    Los Angeles, California, 90095

  • ImClone Investigational Site

    Nashville, Tennessee, 37232

  • ImClone Investigational Site

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Two Tier Study of IMC-A12 in Combination With Depot Octreotide in Patients With Metastatic, Well or Moderately Differentiated Carcinoid or Islet Cell Carcinoma

Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors.

Being tested
Cixutumumab, depot octreotide
Keywords
Islet Cell, CARCINOMA, ISLET CELL, Octreotide, depot octreotide acetate, Insulin-Like Growth Factor (IGF) 1, Metastatic, Carcinoid or Islet Cell, Neuroendocrine Tumors
Medical subject headings
Carcinoma, Neuroendocrine Tumors, Carcinoma, Islet Cell, Neoplasm Metastasis, Carcinoid Tumor

What participants receive

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

  • CixutumumabBiological

    Also called IMC-A12, LY3012217

    Participants will receive cixutumumab IV 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.

  • depot octreotideDrug

    Also called SMS 201-995

    Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.

Study groups in NCT00781911
Study groupRoleWhat they receive
Carcinoid tumorExperimentalParticipants with carcinoid tumor will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
Receives: Biological: Cixutumumab; Drug: depot octreotide
Islet cell carcinomaExperimentalParticipants with islet cell carcinoma will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen.
Receives: Biological: Cixutumumab; Drug: depot octreotide

What is being measured

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

  1. Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months

    Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.

    Measured: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)

Secondary outcomes (10)

  1. Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)

    Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.

    Measured: From Start of Treatment Baseline to Disease Progression (Up to 18 Months)

  2. Percentage of Participants With a Biochemical Response Rate

    Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.

    Measured: From Start of Treatment Up to 18 Months

  3. Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)

    Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

    Measured: 18 months

  4. Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1

    Measured: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion

  5. PK: Half-life (t 1/2) Cycle 1

    Measured: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion

  6. PK: Area Under Concentration (AUCinf) Cycle 1

    Measured: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion

  7. PK: Clearance (CL) Cycle 1

    Measured: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion

  8. PK: Volume at Steady State (Vss) Cycle 1

    Measured: Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion

  9. Serum Anti-Cixutumumab Antibody Assessment

    Measured: 18 months

  10. Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2

    Measured: 18 months

Timeline

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

  1. First posted29 Oct 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionJul 2011
  4. Study completionMay 2016

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781911
Sponsor's protocol ID
13929
Other IDs
CP13-0710, I5A-IE-JAEE
Status last verified
Sep 2019
First submitted
27 Oct 2008
Last updated
20 Sep 2019
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cixutumumab and depot octreotide in people with Carcinoma and Neuroendocrine Tumors, run by Eli Lilly and Company at 10 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 19 inclusion and 12 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months (time frame: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)). 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 NCT00781911.

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 20 Sep 2019.

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