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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:
ClinicalTrials.gov Identifier:
NCT00881166
First Posted: April 15, 2009
Last Update Posted: November 2, 2012
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.
Information provided by (Responsible Party):
Astex Pharmaceuticals
  Purpose

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.


Condition Intervention Phase
Malignant Disease Drug: MP-470 + topotecan Drug: MP-470 + docetaxel Drug: MP-470 + erlotinib Drug: MP-470 + paclitaxel/carboplatin Drug: MP-470 + carboplatin/etoposide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens

Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: March 2010 ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: March 2010 ]
  • Pharmacokinetics, pharmacodynamic effects on biomarker modulation. [ Time Frame: March 2010 ]
  • Experience DLT [ Time Frame: March 2010 ]

Enrollment: 101
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
oral MP-470 + paclitaxel/carboplatin
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
Experimental: 2
oral MP-470 + carboplatin/etoposide
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: 3
oral MP-470 + topotecan
Drug: MP-470 + topotecan
Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
Experimental: 4
oral MP-470 + docetaxel
Drug: MP-470 + docetaxel
Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
Experimental: 5
oral MP-470 + Erlotinib
Drug: MP-470 + erlotinib
150 mg PO once daily at least 1 hour before or 2 hours after eating

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881166


Locations
United States, Arizona
Premiere Oncology
Scottsdale, Arizona, United States, 85258
United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Texas
Audie Murphy Veterans Memorial Hospital (VA)
San Antonio, Texas, United States, 78229
CTRC at the UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapy (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astex Pharmaceuticals
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00881166     History of Changes
Other Study ID Numbers: SGI-0470-02
First Submitted: April 13, 2009
First Posted: April 15, 2009
Last Update Posted: November 2, 2012
Last Verified: October 2012

Keywords provided by Astex Pharmaceuticals:
MP-470
Multi-targeted Tyrosine Kinase Inhibitor
Malignant disease

Additional relevant MeSH terms:
Paclitaxel
Etoposide
Docetaxel
Etoposide phosphate
Albumin-Bound Paclitaxel
Carboplatin
Erlotinib Hydrochloride
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Topoisomerase I Inhibitors