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OpenTrials
Completed

NCT Number: NCT00881166

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Premiere Oncology, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.
  • Must be able to read, understand, and sign the IRB approved Informed Consent Form.
  • At least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.

Exclusion criteria

  • Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.
  • History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
  • 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.
  • Received prior radiation therapy within the past 4 weeks.
  • Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
  • 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.

Treatment and study plan

MP-470 + topotecan

Drug

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

MP-470 + docetaxel

Drug

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

MP-470 + erlotinib

Drug

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

MP-470 + paclitaxel/carboplatin

Drug

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

Drug

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

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: March 2010

Secondary outcomes

  1. Response rate

    Time frame: March 2010

  2. Pharmacokinetics, pharmacodynamic effects on biomarker modulation.

    Time frame: March 2010

  3. Experience DLT

    Time frame: March 2010

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: SGI-0470-02

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2009
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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