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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881166

Acronym

SGI-0470-02

Enrollment

101

Registered

2009-04-15

Start date

2007-11-30

Completion date

2009-12-31

Last updated

2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Disease

Keywords

MP-470, Multi-targeted Tyrosine Kinase Inhibitor, Malignant disease

Brief 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.

Interventions

DRUGMP-470 + topotecan

Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5

DRUGMP-470 + docetaxel

Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1

DRUGMP-470 + erlotinib

150 mg PO once daily at least 1 hour before or 2 hours after eating

DRUGMP-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

DRUGMP-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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD)	March 2010

Secondary

Measure	Time frame
Response rate	March 2010
Pharmacokinetics, pharmacodynamic effects on biomarker modulation.	March 2010
Experience DLT	March 2010

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026