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OpenTrials
Completed

NCT Number: NCT00920205

Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments

The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future.

The study drug is designed to reduce the activity of a protein known as "heat shock protein 90", or "Hsp90". Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.

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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

Nevada Cancer Institute, Las Vegas, Nevada, United States

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About this study

This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • recurrent cancer refractory to available systemic therapy
  • 18 years old or older
  • predicted life expectancy equal or greater to 8 weeks
  • at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
  • Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
  • adequate organ function based on hematological, liver, and renal function
  • LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
  • wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued

Exclusion criteria

  • pregnant or breastfeeding
  • received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
  • symptoms of heart failure equal or greater to Class III (by NYHA criteria)
  • impaired cardiac function or clinically significant cardiac diseases
  • concurrent treatment with medications that either markedly induce or inhibit CYP3A4
  • concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug

Treatment and study plan

MPC-3100 (an Hsp90 inhibitor)

Drug

oral daily dose for 21 days in a 28-day cycle

Primary outcomes

  1. Safety and Tolerability (Maximum Tolerated Dose)

    Time frame: After each cohort is enrolled .

Secondary outcomes

  1. Study Drug Pharmacokinetics

    Time frame: Cycle 1

  2. Evidence of anti-tumor activity of study drug.

    Time frame: After each odd cycle and end of study.

Sponsors and collaborators

Lead sponsor

Myrexis Inc.

Industry

Registry information

Official study title

Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2009
Registry last updated
Oct 14, 2011

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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