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

NCT00881166 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Malignant Disease

Interventions

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 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

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881166 on ClinicalTrials.gov