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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00881166
First received: April 13, 2009
Last updated: October 31, 2012
Last verified: October 2012
History of Changes

April 13, 2009
October 31, 2012
November 2007
December 2009   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00881166 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, pharmacodynamic effects on biomarker modulation. [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Experience DLT [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, pharmacodynamic effects on biomarker modulation. [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00881166
SGI-0470-02
No
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