Solid TumorsPhase 1NCT00591682
MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
A Phase 1 study testing MSX-122 in people with Solid Tumors, run by Metastatix, Inc. at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122 2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122 Secondary Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- MSX-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Mar 2009
- 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
- Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy that provides benefit
- Measurable or non-measurable disease at baseline
- At least four weeks since the last dose of prior chemotherapy, treatment with biologic agents, radiation therapy or investigational agents
- Patients must have recovered from the adverse effects of prior therapy at the time of enrollment to a grade one or less(excluding alopecia)
- Patient will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
- Age >/= 18 year, male or female patients
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- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
- Life expectancy of greater than 3 months following study entry
- Adequate renal function, defined by serum creatinine less than or equal to 1.5 x ULN
- Adequate hepatic function as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels </= to 2.5 x ULN and total bilirubin </= to 1.5 x ULN. In the presence of liver metastasis, adequate hepatic function is defined as ALT and AST </= 5 x ULN and total bilirubin </= 3 x ULN. Alkaline phosphatase levels less than or equal to 2.5 x ULN. In the presence of extensive bone metastases, alkaline phosphatase is defined as less than or equal to 5 x ULN
- Adequate bone marrow function as defined by an absolute neutrophil count of >/= 1,500/mm3 (>/=1.5 x 10^9/L), platelet count of >/= 100,000/mm3 (>/=100 x10^9/L) and hemoglobin of >/= 8 gm/dL
- Left ventricular ejection fraction of 50% or greater as measured by echocardiogram or MUGA
- For women of childbearing potential, a negative serum pregnancy test result at screening
- Women of child-bearing potential or men whose sexual partners are women of child-bearing potential must agree to use two methods of adequate contraception (e.g. hormonal and barrier method of birth control) prior to study entry, for the duration of the study, and for 21 days after the last dose of study medication. Acceptable methods of contraception include condoms, diaphragm ,birth control pills, birth control patch, hormonal injections, intrauterine device (IUD), surgical sterilization and/or under the skin implants
- Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed
Who cannot join
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled arterial hypertension (>/= 140/90 mm of mercury on medications); uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder); altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results
- Patients with a history of a cardiovascular illness including but not confined to: CHF (grade III or IV NYHA); a history of angina pectoris within the previous year; history of any cardiac arrhythmia; QTc prolongation as determined by Bazett's formula and defined as QTc interval >480 msec (including patients on medication which may prolong QTc), or history of myocardial infarction within one year of study enrollment
- Patients with leukemias or myelodysplastic syndrome (MDS)
- Immunocompromised patients, including subjects known to be infected by human immunodeficiency virus (HIV)
- Patients with a history of autologous BMT within the previous five years. Patients with organ transplants, or allogeneic BMT will not be eligible for the study
- Patients with untreated or uncontrolled brain metastasis, or patients with leptomeningeal disease
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- Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (e.g. WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy).
- Patients with a history of major surgery within 28 days of first receipt of study drug
- Nursing or pregnant women
- Patients with any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that in the opinion of the investigator, contraindicates the use of an investigational drug, or that may render the patient at excessively high risk for treatment complications
- Patients with a history of one or more other primary carcinomas
- Patients with a known hypersensitivity to any of the components of the drug product
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Dose Escalation Study to Determine the Safety and Pharmacokinetics of MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
Primary Objectives:
- To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
- To characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122
Secondary Objectives:
- To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
- To evaluate the preliminary evidence for anti-tumor activity of MSX-122
- To perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
- Conditions
- Solid Tumors
- Being tested
- MSX-122
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSX-122Drug
Dosage form = capsule
Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.)
- If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort.
- If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort.
- If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MSX-122 Receives: Drug: MSX-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
Measured: 12 Months Estimated
Characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122
Measured: 12 Months Estimated
Secondary outcomes (3)
Determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
Measured: 12 Months Estimated
Evaluate the preliminary evidence for anti-tumor activity of MSX-122
Measured: 12 Months Estimated
Perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
Measured: 12 Months Estimated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metastatix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer J. Wheler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591682
- Sponsor's protocol ID
- 2007-0407
- Status last verified
- Mar 2008
- First submitted
- 31 Dec 2007
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study to Determine the Safety and Pharmacokinetics of MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00591682
- Acronym / sponsor ID
- 2007-0407
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Metastatix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 11 Jan 2008 (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.
Primary Objectives:
- To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
- To characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122
Secondary Objectives:
- To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
- To evaluate the preliminary evidence for anti-tumor activity of MSX-122
- To perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MSX-122MSX-122 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which there is no standard therapy that provides benefit
- Measurable or non-measurable disease at baseline
- At least four weeks since the last dose of prior chemotherapy, treatment with biologic agents, radiation therapy or investigational agents
- Patients must have recovered from the adverse effects of prior therapy at the time of enrollment to a grade one or less(excluding alopecia)
- Patient will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
Key exclusion criteria (12 listed)
- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled arterial hypertension (>/= 140/90 mm of mercury on medications); uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder); altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results
- Patients with a history of a cardiovascular illness including but not confined to: CHF (grade III or IV NYHA); a history of angina pectoris within the previous year; history of any cardiac arrhythmia; QTc prolongation as determined by Bazett's formula and defined as QTc interval >480 msec (including patients on medication which may prolong QTc), or history of myocardial infarction within one year of study enrollment
- Patients with leukemias or myelodysplastic syndrome (MDS)
- Immunocompromised patients, including subjects known to be infected by human immunodeficiency virus (HIV)
- Patients with a history of autologous BMT within the previous five years. Patients with organ transplants, or allogeneic BMT will not be eligible for the study
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 |
|---|---|---|
| MSX-122Dosage form = capsule Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.) * If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort. * If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort. * If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort. | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
Time frame: 12 Months Estimated
Characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122
Time frame: 12 Months Estimated
3 secondary outcomes
Determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
Time frame: 12 Months Estimated
Evaluate the preliminary evidence for anti-tumor activity of MSX-122
Time frame: 12 Months Estimated
Perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
Time frame: 12 Months Estimated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
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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.
Jennifer J. Wheler, MD principal investigator
M.D. Anderson Cancer Center
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 MSX-122 in people with Solid Tumors, run by Metastatix, 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 15 inclusion and 12 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: paused, as of the sponsor's last update on 26 Mar 2008. 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?
Results are not available in the source record.
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?
Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122 (time frame: 12 Months Estimated). 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?
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 26 Mar 2008.