Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors

Malignant Disease Clinical Trial

— SGI-0470-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881166
• Other study ID #: SGI-0470-02
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2020
• Source: Astex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Disease

Intervention

Drug:
• MP-470 + topotecan
Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
• MP-470 + docetaxel
Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
• MP-470 + erlotinib
150 mg PO once daily at least 1 hour before or 2 hours after eating
• 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
• MP-470 + carboplatin/etoposide
Carboplatin IV infusion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100 mg/m2 IV infusion over 2 hours on Days 1-3

Locations

Country	Name	City	State
United States	Audie Murphy Veterans Memorial Hospital (VA)	San Antonio	Texas
United States	CTRC at the UT Health Science Center at San Antonio	San Antonio	Texas
United States	South Texas Accelerated Research Therapy (START)	San Antonio	Texas
United States	Premiere Oncology	Santa Monica	California
United States	Premiere Oncology	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		March 2010
Secondary	Response rate		March 2010
Secondary	Pharmacokinetics, pharmacodynamic effects on biomarker modulation.		March 2010
Secondary	Experience DLT		March 2010