Advanced CancerPhase 1NCT00606879
Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors
A Phase 1 study testing SGX523 Capsules in people with Advanced Cancer, run by SGX Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- SGX523 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jun 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
- Subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent
- Pathologic evidence of solid tumor
- Failed standard therapy and deemed by the Investigator to be suitable for participation into the trial
- Laboratory values (obtained within 10 days prior to enrollment): ANC: >= 1.5 × 109/L; Platelets: >= 100 × 109/L; Hemoglobin: >= 10.0 g/dL (without transfusions); Bilirubin: within normal range; AST, ALT, and alkaline phosphatase: <= 2.5 x ULN without tumor liver involvement; Serum creatinine: within normal limits; Calculated creatinine clearance: >= 60 mL/min/1.73 m2 for patients with creatinine > Institutional Normal Values; PT/PTT/INR: within normal limits..
- Have IHC evidence of phospho-MET expression on tumor material no more than 12 months old. This is a requirement only for entry into the MTD dose expansion phase.
- Have no residual toxic effects of previous therapy, and undergo a washout period of at least 5 half-lives from the time of administration of the previous therapy.
Who cannot join
- Pregnant, lactating, or may become pregnant
- Cardiac disease requiring medical therapy
- Have had a major surgery within 4 weeks prior to Day 1 of the study
- Have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy
- Have a known active infection with HIV, hepatitis B or C
- Have psychiatric or seizure disorders that would require therapy or interfere with study participation
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- Have other severe concurrent nonmalignant disease that could compromise protocol objectives, including malabsorptive conditions
- Patients receiving prohibited medications as listed in Appendix E, including drugs categorized as strong inhibitors of CYP3A4 and A5 and drugs known to have a high potential risk of liver toxicity
- Have known allergy to SGX523 formulation or its excipients (croscarmellose sodium, lactose monohydrate and magnesium steareate)
- Patients receiving anti-coagulant therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Premier Onocology, California
Santa Monica, California, 90404
About this study
Official title: A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, PK and PkD Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, on a Twice Daily, Uninterrupted Schedule in Patients With Advanced Cancer
SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.
- Conditions
- Advanced Cancer
- Being tested
- SGX523 Capsules
- Keywords
- Solid tumor, Advanced Cancer, MET inhibitor, Receptor Tyrosine Kinase Inhibitor (RTKI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGX523 CapsulesDrug
This is a dose escalation study
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: SGX523 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: Within first 28 Days
Secondary outcomes (1)
PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo
Measured: To 28 Days after patient withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SGX Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee Rosen, MD, Principal investigator, Premier Onocology, CaliforniaHoward Burris, MD, Principal investigator, Sarch Cannon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606879
- Sponsor's protocol ID
- SGX523-1A-002
- Status last verified
- Jul 2008
- First submitted
- 18 Jan 2008
- Last updated
- 24 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, PK and PkD Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, on a Twice Daily, Uninterrupted Schedule in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00606879
- Acronym / sponsor ID
- SGX523-1A-002
- Conditions
- Advanced Cancer
- Keywords
- Solid tumor, Advanced Cancer, MET inhibitor, Receptor Tyrosine Kinase Inhibitor (RTKI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- SGX Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 5 Feb 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.
SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: SGX523 Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent
- Pathologic evidence of solid tumor
- Failed standard therapy and deemed by the Investigator to be suitable for participation into the trial
- Laboratory values (obtained within 10 days prior to enrollment): ANC: >= 1.5 × 109/L; Platelets: >= 100 × 109/L; Hemoglobin: >= 10.0 g/dL (without transfusions); Bilirubin: within normal range; AST, ALT, and alkaline phosphatase: <= 2.5 x ULN without tumor liver involvement; Serum creatinine: within normal limits; Calculated creatinine clearance: >= 60 mL/min/1.73 m2 for patients with creatinine > Institutional Normal Values; PT/PTT/INR: within normal limits..
- Have IHC evidence of phospho-MET expression on tumor material no more than 12 months old. This is a requirement only for entry into the MTD dose expansion phase.
Key exclusion criteria (10 listed)
- Pregnant, lactating, or may become pregnant
- Cardiac disease requiring medical therapy
- Have had a major surgery within 4 weeks prior to Day 1 of the study
- Have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy
- Have a known active infection with HIV, hepatitis B or C
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 |
|---|---|---|
| SGX523 CapsulesThis is a dose escalation study | Drug | Single arm |
Primary outcome
Maximum Tolerated Dose
Time frame: Within first 28 Days
1 secondary outcome
PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo
Time frame: To 28 Days after patient withdrawal
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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.
Lee Rosen, MD principal investigator
Premier Onocology, California
Howard Burris, MD principal investigator
Sarch Cannon Research Institute
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 SGX523 Capsules in people with Advanced Cancer, run by SGX Pharmaceuticals, 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 6 inclusion and 10 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 24 Jul 2008. 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 was stopped early. 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?
Maximum Tolerated Dose (time frame: Within first 28 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 24 Jul 2008.