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Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors (SGI-0470-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00881166
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):

April 13, 2009
April 15, 2009
November 2, 2012
November 2007
December 2009   (Final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) [ Time Frame: March 2010 ]
  • Maximum tolerated dose (MTD) [ Time Frame: March 2010 ]
  • Dose limiting toxicity (DLT) [ Time Frame: March 2010 ]
Complete list of historical versions of study NCT00881166 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: March 2010 ]
  • Pharmacokinetics, pharmacodynamic effects on biomarker modulation. [ Time Frame: March 2010 ]
  • Experience DLT [ Time Frame: March 2010 ]
  • Response rate [ Time Frame: March 2010 ]
  • Pharmacokinetics, pharmacodynamic effects on biomarker modulation. [ Time Frame: March 2010 ]
Not Provided
Not Provided
Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors
Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens

Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm.

Primary objective: Determine the MTD.

Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.

Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Disease
  • Drug: MP-470 + topotecan
    Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
  • Drug: MP-470 + docetaxel
    Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
  • Drug: MP-470 + erlotinib
    150 mg PO once daily at least 1 hour before or 2 hours after eating
  • Drug: MP-470 + paclitaxel/carboplatin
    Paclitaxel 200 mg/m2 IV infusion over 3 hours followed by carboplatin IV infusion over 1 hour to a target AUC of 6 mg∙min/mL on Day 1
  • Drug: MP-470 + carboplatin/etoposide
    Carboplatin IV infustion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100mg/m2 IV infustion over 2 hours on Days 1-3
  • Experimental: 1
    oral MP-470 + paclitaxel/carboplatin
    Intervention: Drug: MP-470 + paclitaxel/carboplatin
  • Experimental: 2
    oral MP-470 + carboplatin/etoposide
    Intervention: Drug: MP-470 + carboplatin/etoposide
  • Experimental: 3
    oral MP-470 + topotecan
    Intervention: Drug: MP-470 + topotecan
  • Experimental: 4
    oral MP-470 + docetaxel
    Intervention: Drug: MP-470 + docetaxel
  • Experimental: 5
    oral MP-470 + Erlotinib
    Intervention: Drug: MP-470 + erlotinib
Mita M, Gordon M, Rosen L, Kapoor N, Choy G, Redkar S, Taverna P, Oganesian A, Sahai A, Azab M, Bristow R, Tolcher AW. Phase 1B study of amuvatinib in combination with five standard cancer therapies in adults with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):195-204. doi: 10.1007/s00280-014-2481-1. Epub 2014 May 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Astex Pharmaceuticals
Astex Pharmaceuticals
Not Provided
Principal Investigator: Anthony Tolcher, MD The START Center for Cancer Care
Principal Investigator: Monica Mita, MD Cancer Therapy and Research Center, Texas
Principal Investigator: Lee Rosen, MD Premiere Oncology
Principal Investigator: Michael Gordon, MD Premiere Oncology
Study Director: Greg Berk, MD Astex Pharmaceuticals
Astex Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP