Solid TumorsPhase 1NCT00658970
Evaluation of KX2-391 in Patients With Advanced Malignancies
A Phase 1 study testing KX2-391 in people with Solid Tumors and Lymphoma, run by Athenex, Inc. at 2 sites in United States.
Trial summary
The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Lymphoma
- What is being tested?
- KX2-391
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to May 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
- Signed written informed consent
- Adults over age 18 years of age
- Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with treated brain or ocular metastases are also eligible
- ECOG performance status of 0-2
- Life expectancy of at least 14 weeks
- Adequate bone marrow reserve
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- Adequate liver function as demonstrated by serum bilirubin, alanine aminotransferase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)
- Adequate renal function (serum creatinine </= 1.5 x ULN or calculated creatinine clearance > 60 ml/min)
- Normal coagulation profile (PT/INR and aPTT within institutional normal limits) for those who give consent to tumor biopsy, within 1 week prior to the procedure.
- Negative pregnancy test for females at Screening, preferably done within 1 week before Day 1 of dosing (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
- Willing to abstain from sexual activity or practice physical barrier contraception 28 days before Day 1 of dosing and 6 months after the last dose for the patient
- Signed written informed consent for tumor biopsy for the additional 10 subjects that will be dosed at the MTD and who have accessible tumors
Who cannot join
- Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer treatment or investigational agents
- Receiving or having received investigational agents or systemic anti-cancer agents within 14 days of Day 1 of dosing or 28 days for those agents with unknown elimination half-lives or half-lives of greater than 50 hours
- Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or skull, </= 4 weeks or low dose palliative radiation therapy limited to limbs </= 1 week prior to starting study drug, or who have not recovered from side effects of such therapy
- Currently taking hormones (i.e., estrogen contraceptives, hormone replacement, anti-estrogen), anti-platelet agents or anti-coagulants, e.g. coumadin, except for those who are on prophylactic doses of anti-coagulants for indwelling venous catheters
- Use of strong inhibitors or inducers of cytochrome P450 3A4 enzymes 2 weeks or 5 half-lives prior to Day 1 of dosing and during the study (refer to Appendix 3)
- Pregnant or breast-feeding
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- Major surgery within 4 weeks prior to Day 1 of dosing
- Major surgery to the upper gastrointestinal tract, or inflammatory bowel disease, malabsorption syndrome or other medical condition that may interfere with oral absorption
- Signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, makes it undesirable for the subject to participate in the study or which could jeopardize compliance with the protocol
- History of angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack or cardiac arrhythmia requiring medical therapy
- Evidence of hepatitis B or C, human immunodeficiency (HIV) infection, coagulation disorders, or hemolytic conditions, e.g. sickle cell anemia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Combined Rising Single-dose (RSD) and Rising Multiple-dose (RMD)Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.
Read the detailed description
The purpose of this first in human study is to determine the safety and pharmacokinetics of KX2-391 in patients with solid tumors and lymphoma, who are refractory to conventional cancer treatments. In addition, pharmacodynamics will be evaluated using biomarkers in peripheral blood mononuclear cells and in tissue biopsy samples.
- Conditions
- Solid Tumors, Lymphoma
- Being tested
- KX2-391
- Keywords
- Open label, Dose escalation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX2-391Drug
2 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose of the drug
Measured: 64 days
Secondary outcomes (1)
Pharmacokinetics, Pharmacodynamics, Efficacy
Measured: 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionMar 2010
- Study completionMay 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aung Naing, M.D., Principal investigator, M.D. Anderson Cancer CenterRoger B Cohen, M.D., Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658970
- Sponsor's protocol ID
- KX01-01-07
- Status last verified
- Jun 2011
- First submitted
- 15 Jan 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Rising Single-dose (RSD) and Rising Multiple-dose (RMD)Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of KX2-391 in Patients With Advanced Malignancies That Are Refractory to Conventional Therapies
- ClinicalTrials.gov ID
- NCT00658970
- Acronym / sponsor ID
- KX01-01-07
- Conditions
- Solid Tumors, Lymphoma
- Keywords
- Open label, Dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Apr 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.
The purpose of this Phase 1 study is to determine the safety and tolerability of KX2-391 in cancer patients.
Detailed description
The purpose of this first in human study is to determine the safety and pharmacokinetics of KX2-391 in patients with solid tumors and lymphoma, who are refractory to conventional cancer treatments. In addition, pharmacodynamics will be evaluated using biomarkers in peripheral blood mononuclear cells and in tissue biopsy samples.
Study design
- Primary purpose
- Treatment
- 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 (12 listed)
- Signed written informed consent
- Adults over age 18 years of age
- Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with treated brain or ocular metastases are also eligible
- ECOG performance status of 0-2
- Life expectancy of at least 14 weeks
Key exclusion criteria (11 listed)
- Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer treatment or investigational agents
- Receiving or having received investigational agents or systemic anti-cancer agents within 14 days of Day 1 of dosing or 28 days for those agents with unknown elimination half-lives or half-lives of greater than 50 hours
- Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or skull, </= 4 weeks or low dose palliative radiation therapy limited to limbs </= 1 week prior to starting study drug, or who have not recovered from side effects of such therapy
- Currently taking hormones (i.e., estrogen contraceptives, hormone replacement, anti-estrogen), anti-platelet agents or anti-coagulants, e.g. coumadin, except for those who are on prophylactic doses of anti-coagulants for indwelling venous catheters
- Use of strong inhibitors or inducers of cytochrome P450 3A4 enzymes 2 weeks or 5 half-lives prior to Day 1 of dosing and during the study (refer to Appendix 3)
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 |
|---|---|---|
| KX2-3912 mg (starting dose)rising dose, oral dosing, twice daily, 21 day cycle(s); until progression or unacceptable toxicity develops | Drug | – |
Primary outcome
Determine maximum tolerated dose of the drug
Time frame: 64 days
1 secondary outcome
Pharmacokinetics, Pharmacodynamics, Efficacy
Time frame: 64 days
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 8 Jun 2011.
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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.
Aung Naing, M.D. principal investigator
M.D. Anderson Cancer Center
Roger B Cohen, M.D. principal investigator
Fox Chase Cancer Center
2 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 KX2-391 in people with Solid Tumors and Lymphoma, run by Athenex, Inc. at 2 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 12 inclusion and 11 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Determine maximum tolerated dose of the drug (time frame: 64 days). 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 8 Jun 2011.