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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
South Texas Accelerated Research Therapy (START)
San Antonio, Texas, United States, 78229
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
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

No publications provided

Responsible Party: Astex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00881166     History of Changes
Other Study ID Numbers: SGI-0470-02
Study First Received: April 13, 2009
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014