A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
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Purpose
A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Biological: IMC-3C5 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available |
- Number of Participants with Adverse Events [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose (MTD) [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: Yes ]
- Antitumor activity of single agent IMC-3C5 [ Time Frame: Approximately 36 Months ] [ Designated as safety issue: No ]Tumor response assessment will be done by computed tomography (CT) scan or Magnetic resonance imaging (MRI) every 6 or 8 weeks through out the study
- Minimum concentration (Cmin) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
- Area Under the Curve (AUC) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
- Terminal half-life (t1/2) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
- Volume of distribution at steady state (Vss) [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
- Pharmacokinetics - Clearance (Cl) of IMC-3C5 [ Time Frame: Up to Week 30 ] [ Designated as safety issue: No ]
- Anti-IMC-3C5 Antibody Assessment [ Time Frame: Up to Week 30 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IMC-3C5
Patients receiving IMC-3C5 intravenously
|
Biological: IMC-3C5
Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
Other Name: LY3022856
|
Detailed Description:
This multicenter study will enroll approximately 40 subjects. The actual sample size will vary depending on how many subjects are needed to obtain at least 3 complete subjects per cohort.
IMC-3C5 will initially be administered once every week (Cohorts 1-4) in a dose escalated manner. The starting dose will be 5mg/kg weekly (Cohort 1). Dose escalation will proceed to 10mg/kg (Cohort 2), 20 mg/kg (Cohort 3), and 30mg/kg (Cohort 4). Based on an analysis of the safety and pharmacokinetic profile of weekly dosing, subjects may be enrolled sequentially into 2 every-other-week dose cohorts (Cohorts 5-6, 20mg/kg and 30mg/kg). Intermediate doses may also be used.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has histologic or cytologic confirmation of cancer
- Subject has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
- Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Subject has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable)
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
- Subject has adequate hematologic, hepatic, renal, and coagulation function
- Subject has a life expectancy greater than 3 months
- Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent
Exclusion Criteria:
- Subject has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
- Subject has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
- Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
- Subject has an ongoing or active infection (except as outlined in Exclusion Criterion #11), congestive heart failure, active bleeding or any other serious uncontrolled medical disorder
- Subject has known or suspected untreated brain or leptomeningeal metastases
- Subject has uncontrolled hypertension
- Subject has received an organ transplant
- Subject has a serious or nonhealing wound, ulcer, or bone fracture
- Subject has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
- Subject currently has peripheral edema requiring diuresis or anasarca
- Subject has Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), except subjects who have been on a stable antiviral regimen for at least 12 weeks, have a viral load of < 50 copies/mL, and a CD4 count of ≥ 200 cells/mm3
- Subject is currently using or has received a thrombolytic agent within 28 days prior to enrollment
- Subject is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
- Subject if female, is pregnant or is lactating
Contacts and Locations| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
| United States, Indiana | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: ImClone | |
| United States, Massachusetts | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: ImClone | |
| United States, New York | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: ImClone | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | ImClone LLC |
More Information
No publications provided
| Responsible Party: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT01288989 History of Changes |
| Other Study ID Numbers: | 14247, CP23-1001, I5G-IE-JBCA |
| Study First Received: | January 31, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ImClone LLC:
|
Advanced Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013