Know Cancer

or
forgot password

Phase 1 Study of the Anti-Ron Receptor Monoclonal Antibody IMC-RON8 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

Phase 1 Study of the Anti-Ron Receptor Monoclonal Antibody IMC-RON8 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available


Inclusion Criteria:



- The patient has histologically-confirmed advanced primary or recurrent solid tumors
that have not responded to standard therapy or for which no standard therapy is
available

- The patient has measurable or non-measurable disease

- The patient has not received major surgery, prior chemotherapy, prior treatment with
an investigational agent or device, or prior radiation therapy within 28 days prior
to the first dose of study therapy

- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS)
score of 0-2

- The patient has adequate hematologic function

- The patient has adequate renal function as defined by serum creatinine ≤ 1.5 x the
institutional ULN

- The patient has a life expectancy > 3 months

Exclusion Criteria:

- The patient has received chemotherapy or therapeutic radiation therapy within 28 days
prior to the first dose of study therapy

- The patient has ongoing toxicities of > Grade 1 associated with any prior treatment

- The patient has a known sensitivity to monoclonal antibodies or other therapeutic
agents, or to agents of similar biologic composition as IMC-RON8

- The patient has received treatment with any monoclonal antibodies within 6 weeks
prior to first dose of study therapy

- The patient has received treatment with agents specifically targeting the Ron ligand
or receptor within 6 weeks prior to first dose of study therapy

- The patient has undergone a major surgical procedure, open biopsy, or experienced a
significant traumatic injury within 28 days prior to the first dose of study therapy

- The patient has an ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial
fibrillation is permitted), psychiatric illness/social situations, active bleeding,
or any other serious uncontrolled medical disorders in the opinion of the
investigator

- The patient has known or suspected brain or leptomeningeal metastases (patients with
a history of brain metastases must have received definitive surgery or radiotherapy,
be clinically stable, and may not be taking steroids; patients receiving
anticonvulsants are eligible)

- The patient has a serious or nonhealing active wound, ulcer, or bone fracture

- The patient is currently using or has received a thrombolytic agent within 28 days
prior to first dose of study therapy

- The patient is receiving full-dose warfarin (patients receiving low-dose warfarin to
maintain the patency of permanent, indwelling intravenous catheters are eligible if
the international normalized ratio is < 1.5)

- The patient is receiving intravenous heparin

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety profile and maximum tolerated dose (MTD) of IMC-RON8

Outcome Time Frame:

36 Months

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13958

NCT ID:

NCT01119456

Start Date:

May 2010

Completion Date:

September 2013

Related Keywords:

  • Cancer
  • Tumors
  • Macrophage stimulating 1 receptor, human
  • RON protein
  • RON receptor protein tyrosine kinase

Name

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.Manhassaet, 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.Indianapolis, Indiana  46227
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.Kalamazoo, Michigan  49048