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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety and Tolerability (Maximum Tolerated Dose)

Outcome Time Frame:

After each cohort is enrolled .

Safety Issue:

Yes

Principal Investigator

Andrew Beelen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Institutional Review Board

Study ID:

MPC-3100-001

NCT ID:

NCT00920205

Start Date:

June 2009

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • MPC-3100
  • HSP90 inhibitor
  • oral drug
  • cancer

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Nevada Cancer Institute Las Vegas, Nevada  89135
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229