CancerPhase 1NCT00920205
Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments
A Phase 1 study testing MPC-3100 (an Hsp90 inhibitor) in people with Cancer, run by Myrexis Inc. at 3 sites in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- MPC-3100 (an Hsp90 inhibitor)
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- MPC-3100 (an Hsp90 inhibitor)
- Keywords
- MPC-3100, HSP90 inhibitor, oral drug, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPC-3100 (an Hsp90 inhibitor)Drug
oral daily dose for 21 days in a 28-day cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability (Maximum Tolerated Dose)
Measured: After each cohort is enrolled .
Secondary outcomes (2)
Study Drug Pharmacokinetics
Measured: Cycle 1
Evidence of anti-tumor activity of study drug.
Measured: After each odd cycle and end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Beelen, MD, Study director, Myrexis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920205
- Sponsor's protocol ID
- MPC-3100-001
- Status last verified
- Oct 2011
- First submitted
- 12 Jun 2009
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bagatell R, Whitesell L. Altered Hsp90 function in cancer: a unique therapeutic opportunity. Mol Cancer Ther. 2004 Aug;3(8):1021-30.
PubMed 15299085Maloney 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.
PubMed 11772336
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
- ClinicalTrials.gov ID
- NCT00920205
- Acronym / sponsor ID
- MPC-3100-001
- Conditions
- Cancer
- Keywords
- MPC-3100, HSP90 inhibitor, oral drug, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPC-3100 (an Hsp90 inhibitor)oral daily dose for 21 days in a 28-day cycle | Drug | – |
Primary outcome
Safety and Tolerability (Maximum Tolerated Dose)
Time frame: After each cohort is enrolled .
2 secondary outcomes
Study Drug Pharmacokinetics
Time frame: Cycle 1
Evidence of anti-tumor activity of study drug.
Time frame: After each odd cycle and end of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2011.
- Background: PubMed 15299085Bagatell R, Whitesell L. Altered Hsp90 function in cancer: a unique therapeutic opportunity. Mol Cancer Ther. 2004 Aug;3(8):1021-30.
- Background: PubMed 11772336Maloney 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.
- Myriad Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Beelen, MD study director
Myrexis Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MPC-3100 (an Hsp90 inhibitor) in people with Cancer, run by Myrexis Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (Maximum Tolerated Dose) (time frame: After each cohort is enrolled .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00920205, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2011.