Colon CancerPhase 2NCT01111838
Clinical and Translational Study of STA-9090
A Phase 2 study testing STA-9090 in people with Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad STA-9090 has on colorectal cancer. This is a phase II trial which tests both how well the drug works in fighting your cancer as well as any possible side effects it will have on the patient. Cancer is a disease of uncontrolled growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- STA-9090
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2012
- Phase
- Phase 2
- 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
- The patient has histologically or cytologically-confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies.
- The patient has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), measuring ≥20 mm on conventional measurement techniques or ≥10 mm on spiral computed tomography (CT) scan.
- The patient has received at least one prior standard and/or investigational regimen for metastatic disease.
- The patient is age ≥18 years.
- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (Karnofsky≥ 80%).
- The patient has adequate hematologic function as defined by an absolute neutrophil count ≥1500/μL, hemoglobin ≥9/μdL, and a platelet count ≥100,000/μL.
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- The patient has adequate hepatic function as defined by a total bilirubin ≤ 2.5x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT)≤3 x the ULN (or ≤5 x the ULN in the presence of known liver metastases).
- The patient, if not on anticoagulation, has adequate coagulation function as defined by international normalized ratio (INR) ≤1.5 ULN and partial thromboplastin time (PTT) ≤1.5x the ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulation or low molecular weight heparin, must have an INR value within acceptable range for treatment and have no active bleeding or pathological condition that, in the opinion of the investigator, carries a high risk of bleeding.
- The patient has adequate renal function as defined by serum creatinine ≤1.5 x the institutional ULN or creatinine clearance ≥60 mL/min for patients with creatinine levels above 1.5, as well as urine protein ≤1+ on routine analysis (if routine UA indicates ≥2+ protein, a 24-hour urine collection for protein must demonstrate < 1000mg of protein in 24 hours to allow participation in the study).
- The patient has a life expectancy of > 3 months.
- Because the teratogenicity of STA-9090 is not known, men and women of childbearing potential must agree to use adequate contraception (hormonal or barrier birth control; abstinence) prior to study entry and for the duration of study participation.
- The patient has the ability to read and willingness to sign informed consent.
- For stage I of the protocol (the first 15 patients) the tumor must be amenable to biopsy and the patient must be willing to undergo pre and post treatment biopsies.
- The patient must have a normal QTc interval on baseline ECG , (<470 milliseconds, males and females).
Who cannot join
- Patient may not have received chemotherapy within 4 weeks prior to entering the study, and must have recovered (to grade 1 or less) from adverse events due to agents administered.
- Primary brain tumors or active brain metastases. However, patients with a history of CNS metastases will be eligible if they have been treated and are stable for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for a minimum of 2 weeks prior to enrollment.
- History of stroke within 6 months of treatment or other significant neurological limitations.
- Major surgery within 4 weeks prior to entering the study.
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration. Study drug administration via indwelling catheters is prohibited at this time.
- Use of any investigational agents within 4 weeks prior to entering the study.
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- History of severe allergic reactions to excipients (e.g., Polyethylene glycol 300 and Polysorbate 80), including severe hypersensitivity reactions defined as ≥ Grade 3 based on NCI CTCAE version 3.
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation or systemic steroids for treatment of autoimmune disease). However, patients may receive steroids for stable CNS metastases as described in exclusion criterion 2.
- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Ventricular ejection fraction (Ef) ≤ 45%.
- Inaccessible tissue for biopsy (first 15 patients only)
- History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
- History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
- New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
- Current or prior radiation therapy to the left hemithorax
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase II Clinical and Translational Study of STA-9090 in Patients With Refractory Metastatic Colorectal Cancer
The purpose of this study is to find out what effects, good and/or bad STA-9090 has on colorectal cancer. This is a phase II trial which tests both how well the drug works in fighting your cancer as well as any possible side effects it will have on the patient.
Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer grow. This study will also look at molecular markers that may affect how the cancer grows, and how it responds to treatment.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- STA-9090
- Keywords
- STA-9090, colon, rectal, 10-029
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-9090Drug
Patients will be enrolled and receive 200mg/m2 of STA-9090. Patients will receive single agent STA-9090 intravenous (I.V.) infusion (an indwelling catheter may not be used) over 60 minutes weekly (three weeks on and one week off). Follow-up imaging will be performed every 8 weeks to evaluate response.
| Study group | Role | What they receive |
|---|---|---|
| STA-9090 | Experimental | This is an open-label Phase 2 clinical study in patients with advanced colorectal cancer (CRC). Patients will be treated with 200mg/m2 of STA-9090 during a 1-hour intravenous infusion 1 time per week for three consecutive weeks followed by a 1 week dose-free interval. Patients tolerating STA-9090 will be permitted to continue treatment until disease progression. Receives: Drug: STA-9090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine Overall Objective Response.
Patients with measurable disease will be evaluated using RECIST criteria for determination of response.
Measured: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
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 Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Synta Pharmaceuticals Corp.
- Responsible party
- Sponsor
- Investigators
- Andrea Cercek, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111838
- Sponsor's protocol ID
- 10-029
- Status last verified
- Oct 2015
- First submitted
- 26 Apr 2010
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical and Translational Study of STA-9090 in Patients With Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01111838
- Acronym / sponsor ID
- 10-029
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- STA-9090, colon, rectal, 10-029
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Synta Pharmaceuticals Corp.
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 20 Nov 2015
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 find out what effects, good and/or bad STA-9090 has on colorectal cancer. This is a phase II trial which tests both how well the drug works in fighting your cancer as well as any possible side effects it will have on the patient.
Cancer is a disease of uncontrolled growth. This growth is controlled in part by a series of proteins that are part of a growth pathway. Some of these proteins are destroyed by a protein called HSP90 and STA-9090 is a test drug which blocks one of the proteins that helps cancer grow. This study will also look at molecular markers that may affect how the cancer grows, and how it responds to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STA-9090 | Experimental | Drug: STA-9090This is an open-label Phase 2 clinical study in patients with advanced colorectal cancer (CRC). Patients will be treated with 200mg/m2 of STA-9090 during a 1-hour intravenous infusion 1 time per week for three consecutive weeks followed by a 1 week dose-free interval. Patients tolerating STA-9090 will be permitted to continue treatment until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient has histologically or cytologically-confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies.
- The patient has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), measuring ≥20 mm on conventional measurement techniques or ≥10 mm on spiral computed tomography (CT) scan.
- The patient has received at least one prior standard and/or investigational regimen for metastatic disease.
- The patient is age ≥18 years.
- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (Karnofsky≥ 80%).
Key exclusion criteria (16 listed)
- Patient may not have received chemotherapy within 4 weeks prior to entering the study, and must have recovered (to grade 1 or less) from adverse events due to agents administered.
- Primary brain tumors or active brain metastases. However, patients with a history of CNS metastases will be eligible if they have been treated and are stable for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for a minimum of 2 weeks prior to enrollment.
- History of stroke within 6 months of treatment or other significant neurological limitations.
- Major surgery within 4 weeks prior to entering the study.
- Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration. Study drug administration via indwelling catheters is prohibited at this time.
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 |
|---|---|---|
| STA-9090Patients will be enrolled and receive 200mg/m2 of STA-9090. Patients will receive single agent STA-9090 intravenous (I.V.) infusion (an indwelling catheter may not be used) over 60 minutes weekly (three weeks on and one week off). Follow-up imaging will be performed every 8 weeks to evaluate response. | Drug | STA-9090 |
Primary outcome
To Determine Overall Objective Response.
Time frame: every 8 weeks
Patients with measurable disease will be evaluated using RECIST criteria for determination of response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Andrea Cercek, MD principal investigator
Memorial Sloan Kettering 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 2 study testing STA-9090 in people with Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center 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 14 inclusion and 16 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 20 Nov 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Nov 2015). 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?
To Determine Overall Objective Response. (time frame: every 8 weeks). 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 20 Nov 2015.