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

NCT00785941 | Completed Phase 1

• 3 other identifiers: 13933CP13-0502I5A-IE-JAEI
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Tumors; Antibodies, Monoclonal

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events (AEs)

  8 weeks

• Maximum Tolerated Dose

  8 weeks

Secondary Outcomes (8)

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

  8 weeks

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

  8 weeks

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

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (1)

IMC-A12

EXPERIMENTAL

All 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.

Biological: IMC-A12

Interventions

IMC-A12 BIOLOGICAL

Cohort 1 6 mg/kg I.V., once every other week for 4 weeks

Also known as: Cixutumumab

IMC-A12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ImClone Investigational Site

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 25749986 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

cixutumumab

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: April 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

US (1)