Know Cancer

or
forgot password

Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Disease

Thank you

Trial Information

Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens


Inclusion Criteria:



1. Malignant disease appropriate for initiating treatment with
carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.

2. Must be able to read, understand, and sign the IRB approved Informed Consent Form.

3. At least 18 years old.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

5. Adequate bone marrow function; normal renal and hepatic function, normal cardiac
function.

Exclusion Criteria:

1. Any other active invasive malignancy except non-melanoma skin cancers or cervical
carcinoma in situ.

2. History of significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure and/or myocardial infarction.

3. Received any anticancer agent(s) within the past 3 weeks, including investigational
agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic
or hormonal therapy other than LHRH agonists.

4. Received prior radiation therapy within the past 4 weeks.

5. Any serious, uncontrolled active infection that requires systemic treatment or known
infection with HIV, HCV or HBV.

6. Patient requires treatment with immunosuppressive agents other than corticosteroids
appropriate for the SOC chemotherapy regimen or those at stable doses for at least 2
weeks.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Time Frame:

March 2010

Safety Issue:

Yes

Principal Investigator

Anthony Tolcher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The START Center for Cancer Care

Authority:

United States: Food and Drug Administration

Study ID:

SGI-0470-02

NCT ID:

NCT00881166

Start Date:

November 2007

Completion Date:

December 2009

Related Keywords:

  • Malignant Disease
  • MP-470
  • Multi-targeted Tyrosine Kinase Inhibitor
  • Malignant disease

Name

Location

Premiere OncologySanta Monica, California  90404
Premiere OncologyScottsdale, Arizona  85260
South Texas Accelerated Research Therapy (START)San Antonio, Texas  78229
Audie Murphy Veterans Memorial Hospital (VA)San Antonio, Texas  78229
CTRC at the UT Health Science Center at San AntonioSan Antonio, Texas  78229