Clinical trial NCT00920205: Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments
Official title: Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: MPC-3100
HSP90 inhibitor
oral drug
cancer
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability (Maximum Tolerated Dose)
timeFrame: After each cohort is enrolled .
Secondary outcomes:
measure: Study Drug Pharmacokinetics
timeFrame: Cycle 1
measure: Evidence of anti-tumor activity of study drug.
timeFrame: After each odd cycle and end of study.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Myrexis Inc.
name: Andrew Beelen, MD
role: STUDY_DIRECTOR
References:
citation: Bagatell R, Whitesell L. Altered Hsp90 function in cancer: a unique therapeutic opportunity. Mol Cancer Ther. 2004 Aug;3(8):1021-30.
citation: Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. doi: 10.1517/14712598.2.1.3.