NCT01288989

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

January 31, 2011

Results QC Date

March 11, 2019

Last Update Submit

March 11, 2019

Conditions

Neoplasms

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Adverse Events (AEs)

    AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.

    Baseline up to 46 months

  • Number of Participants Reporting Dose-Limiting Toxicity (DLT)

    A DLT was defined as any adverse event (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0) considered by the investigator to be definitely, probably, or possibly related to IMC-3C5, that occurred during the DLT Assessment Period (weeks 1 through 6) as follows: * Any Grade 3 or 4 hematologic toxicity * Any Grade 3 or 4 nonhematologic toxicity (excluding fatigue or anorexia lasting \<7 days, or Grade 3 nausea and/or vomiting that persisted for \<2 days following appropriate supportive care intervention)

    Baseline up to 16 Months

Secondary Outcomes (10)

  • Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)

    Baseline up to 46 Months

  • Maximum Concentration (Cmax) of IMC-3C5 - First Infusion

    Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. Prior to 1st infusion and 1 hour post infusion for cohort 5. (Cycle 1 = 4 - 6 weeks.)

  • Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion

    Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)

  • Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion

    Prior to 4th infusion (approximately Day 22, Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. Prior to 4th infusion, 1 hour post infusion for cohort 5. (Cycle 1 = 4-6 weeks.)

  • Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion

    Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)

  • +5 more secondary outcomes

Study Arms (1)

IMC-3C5

EXPERIMENTAL

Participants receiving IMC-3C5 intravenously

Biological: IMC-3C5

Interventions

IMC-3C5BIOLOGICAL

Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week

Also known as: LY3022856
IMC-3C5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has histologic or cytologic confirmation of cancer
  • Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
  • Participant has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  • Participant has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable)
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
  • Participant has adequate hematologic, hepatic, renal, and coagulation function
  • Participant has a life expectancy greater than 3 months
  • Participant agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent

You may not qualify if:

  • Participant has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5
  • Participant has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment
  • Participant has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
  • Participant has known or suspected untreated brain or leptomeningeal metastases
  • Participant has uncontrolled hypertension
  • Participant has received an organ transplant
  • Participant has a serious or nonhealing wound, ulcer, or bone fracture
  • Participant has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment
  • Participant currently has peripheral edema requiring diuresis or anasarca
  • Participant 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
  • Participant is currently using or has received a thrombolytic agent within 28 days prior to enrollment
  • Participant is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation
  • Participant if female, is pregnant or is lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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.

Peoria, Illinois, 61615, United States

Location

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.

Indianapolis, Indiana, 46202, United States

Location

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.

Boston, Massachusetts, 02111, United States

Location

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.

New York, New York, 10029, United States

Location

Related Publications (1)

  • Saif MW, Knost JA, Chiorean EG, Kambhampati SR, Yu D, Pytowski B, Qin A, Kauh JS, O'Neil BH. Phase 1 study of the anti-vascular endothelial growth factor receptor 3 monoclonal antibody LY3022856/IMC-3C5 in patients with advanced and refractory solid tumors and advanced colorectal cancer. Cancer Chemother Pharmacol. 2016 Oct;78(4):815-24. doi: 10.1007/s00280-016-3134-3. Epub 2016 Aug 26.

    PMID: 27566701DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

LY3022856

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 3, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 17, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-03

Locations

US(4)