CancerPhase 1NCT00387153

Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer

A Phase 1 study testing MPC-2130 in people with Cancer, run by Myriad Therapeutics, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer. 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-2130
Type of treatment: Injection or infusion
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Aug 2005to Oct 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study related procedures;
Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
Have measurable or evaluable neoplastic disease;
Be greater than or equal to age 18;
Have and ECOG Performance Status score of less than or equal to 2;
Have adequate organ function defined by:

Show all 12Show fewer

Liver function tests (AST \& ALT) less than or equal to 3 times the upper limit of normal (ULN);
Bilirubin less than or equal to 1.5 X ULN;
Serum Creatinine less than or equal to 1.5 X ULN;
Hemoglobin greater than or equal to 8.0 g/dL;
Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.

Who cannot join

Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
Be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records);
Receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (LHRH) therapy while in this study;
Have previously enrolled in this trial. -

Trial locations and contacts

1 site in 1 country.

United States1 site

MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase 1 OL, Dose Escalating, Multiple Dose Study To Determine The Safety, Tolerability, MTD, And Pharmacokinetics Of MPC-2130 Administered As Daily IV Infusions For 5 Days, Repeated Every 21 Days, In Patients With Refractory Cancer

Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

Read the detailed description

MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.

Conditions: Cancer
Being tested: MPC-2130
Keywords: Oncology, Cancer, Blood Cancers
Medical subject headings: Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MPC-2130Drug
MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.
Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia.
An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation.
Measured: First 21 days on treatment (Cycle 1)
Pharmacokinetics
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.
Measured: First 5 days of treatment (Cycle 1)

Secondary outcomes (1)

Antiproliferative Activity
Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.
Measured: Every 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Oct 2006

First posted12 Oct 2006 (estimated)
Study startAug 2005
Primary completionOct 2006
Study completionOct 2006

Why it stopped: Last subject enrolled experienced bradycardia; study was terminated by Sponsor.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00387153
Sponsor's protocol ID: MPC-2130-04-002
Status last verified: Oct 2009
First submitted: 10 Oct 2006
Last updated: 3 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 OL, Dose Escalating, Multiple Dose Study To Determine The Safety, Tolerability, MTD, And Pharmacokinetics Of MPC-2130 Administered As Daily IV Infusions For 5 Days, Repeated Every 21 Days, In Patients With Refractory Cancer
ClinicalTrials.gov ID: NCT00387153
Acronym / sponsor ID: MPC-2130-04-002
Conditions: Cancer
Keywords: Oncology, Cancer, Blood Cancers
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Last subject enrolled experienced bradycardia; study was terminated by Sponsor.
Enrolment: 8 participants (actual)
Lead sponsor: Myriad Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Oct 2006 (actual)
Study completion: Oct 2006 (actual)
First posted: 12 Oct 2006 (estimated)
Results: Posted 22 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
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 (12 listed)

Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study related procedures;
Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
Have measurable or evaluable neoplastic disease;
Be greater than or equal to age 18;
Have and ECOG Performance Status score of less than or equal to 2;

Key exclusion criteria (4 listed)

Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
Be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records);
Receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (LHRH) therapy while in this study;
Have previously enrolled in this trial. -

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-2130MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours	Drug	–

Primary outcome

Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.
Time frame: First 21 days on treatment (Cycle 1)
Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia. An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation.
Pharmacokinetics
Time frame: First 5 days of treatment (Cycle 1)
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.

1 secondary outcome

Antiproliferative Activity
Time frame: Every 42 days

Results and safety

Results posted to the registry on 22 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MPC-2130 Group 1	8	0

Primary outcome: Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.

Time frame: First 21 days on treatment (Cycle 1). Number. Unit: Participants

Measure	MPC-2130 Group 1 n = 8
Value	8

Population analysed: A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.

Primary outcome: Pharmacokinetics

Time frame: First 5 days of treatment (Cycle 1)

The sponsor has not posted figures for this outcome.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MPC-2130 Group 1	3 of 8 (37.5%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
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Enrolling by invitationPhase 2
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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.

Richard Wenstrup, MD study director

Myriad Therapeutics, Inc.

1 site 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-2130 in people with Cancer, run by Myriad Therapeutics, Inc. at 1 site 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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 22 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4. (time frame: First 21 days on treatment (Cycle 1)). The study lists 2 primary outcomes in all. 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 NCT00387153.

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 3 Nov 2009.