Advanced or Metastatic Solid TumorsPhase 1NCT00276913
A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study testing STA-5312 in people with Advanced or Metastatic Solid Tumors, run by Synta Pharmaceuticals Corp. at 1 site in United States.
Trial summary
Primary Objectives: To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic solid tumors. To determine the pharmacokinetics of STA-5312. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- STA-5312
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to not given
- 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
- Male and female subjects aged at least 18 years with histologically-confirmed non hematological malignancy that is metastatic or unresectable and for which no standard therapy exists.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
- Peripheral neuropathy less than Grade 2 on National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3 adverse event scale.
- Subjects must have acceptable organ and marrow function during the Screening Period as defined below. (Note: Subjects must meet these criteria at each pre-dose visit to receive additional doses of STA-5312).
- Absolute neutrophil count (ANC) greater than 1500 cells/µL
- Platelets greater than 100,000/µL
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- Total bilirubin must be <1.5 times ULN
- Aspartate transaminase (AST) ≤3 times ULN or less than 5 times the ULN in subjects with liver metastases
- Alanine transaminase (ALT) ≤3 times ULN or less than 5 times the ULN in subjects with liver metastases
- Adequate renal function (serum creatinine <2.0 mg/dL).
- Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or active ischemia as determined by the investigator.
- Documented cardiac ejection fraction greater than 50% obtained within 30 days of administration of the first dose.
- The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women over 50 years of age or history of amenorrhea for <12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Women who are pregnant or breast-feeding.
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Subjects with previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
- Subjects with primary brain tumors or active brain metastases are excluded. Subjects with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants are eligible.
- History of stroke within 6 months of treatment or other significant neurological limitations.
- Use of any investigational agents within 4 weeks of study enrollment.
- History of severe allergic reactions to excipients (e.g. Tween 80/polysorbate 80), including severe hypersensitivity reactions defined as greater than Grade 3 based on NCI CTC version 3.
- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steven Limentani, MD
Charlotte, North Carolina, 28203
About this study
Official title: A Phase I Study of STA-5312 Administered Weekly in Subjects With Advanced or Metastatic Solid Tumors
Primary Objectives:
- To determine the safety, toxicity and the maximum tolerated dose (MTD) of intravenous STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic solid tumors.
- To determine the pharmacokinetics of STA-5312.
Secondary Objective:
- To assess antitumor activity of STA-5312 administration.
Read the detailed description
This is a Phase I open-label, dose-escalation safety study in subjects with refractory non hematologic malignancies. STA-5312 will be administered intravenously. Administration is anticipated to take 1 hour, although infusion time may be extended when appropriate with large infusion volumes. A treatment cycle is 4 weeks with a weekly infusion of STA 5312 for the first 3 weeks of each 4 week cycle. The planned treatment schedule is 2 cycles of STA-5312 treatment (8 weeks). Decisions regarding dose escalation and DLT determination will be made based on observations during the first cycle of therapy. Subjects who tolerate treatment may be eligible to continue receiving additional cycles of STA 5312 per the investigator's medical judgment. Evaluation of antitumor response will be performed after every 2 cycles of STA 5312 administration.
The initial dose level of STA 5312 will be 6 mg/m2. The starting dose level was chosen based on preclinical animal studies that used alternate day dosing x 3/week on alternate weeks. The dose level of 6 mg/m2 represents less than 1/10 the weekly dose (3 mg/m2 x 3) that demonstrated severe toxicity. Subsequent dose escalations will follow an accelerated titration design once the 8 mg/m2 cohort is completed No fewer than 3 patients will be enrolled at each dose level. Once a DLT is observed the cohort will be expanded to at least six subjects. If one-third of at least 6 subjects treated at a dose level experience a DLT, dose escalation will terminate. The dose below this will be considered the MTD and will be expanded to at least 12 subjects to collect additional safety and pharmacokinetic data. No intrasubject dose escalations will occur.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- STA-5312
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-5312Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276913
- Sponsor's protocol ID
- 5312-02
- Status last verified
- Jan 2014
- First submitted
- 11 Jan 2006
- Last updated
- 3 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of STA-5312 Administered Weekly in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00276913
- Acronym / sponsor ID
- 5312-02
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Synta Pharmaceuticals Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 13 Jan 2006 (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 safety, toxicity and the maximum tolerated dose (MTD) of intravenous STA-5312 when administered weekly (3 of 4 weeks) to subjects with advanced or metastatic solid tumors.
- To determine the pharmacokinetics of STA-5312.
Secondary Objective:
- To assess antitumor activity of STA-5312 administration.
Detailed description
This is a Phase I open-label, dose-escalation safety study in subjects with refractory non hematologic malignancies. STA-5312 will be administered intravenously. Administration is anticipated to take 1 hour, although infusion time may be extended when appropriate with large infusion volumes. A treatment cycle is 4 weeks with a weekly infusion of STA 5312 for the first 3 weeks of each 4 week cycle. The planned treatment schedule is 2 cycles of STA-5312 treatment (8 weeks). Decisions regarding dose escalation and DLT determination will be made based on observations during the first cycle of therapy. Subjects who tolerate treatment may be eligible to continue receiving additional cycles of STA 5312 per the investigator's medical judgment. Evaluation of antitumor response will be performed after every 2 cycles of STA 5312 administration.
The initial dose level of STA 5312 will be 6 mg/m2. The starting dose level was chosen based on preclinical animal studies that used alternate day dosing x 3/week on alternate weeks. The dose level of 6 mg/m2 represents less than 1/10 the weekly dose (3 mg/m2 x 3) that demonstrated severe toxicity. Subsequent dose escalations will follow an accelerated titration design once the 8 mg/m2 cohort is completed No fewer than 3 patients will be enrolled at each dose level. Once a DLT is observed the cohort will be expanded to at least six subjects. If one-third of at least 6 subjects treated at a dose level experience a DLT, dose escalation will terminate. The dose below this will be considered the MTD and will be expanded to at least 12 subjects to collect additional safety and pharmacokinetic data. No intrasubject dose escalations will occur.
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 (14 listed)
- Male and female subjects aged at least 18 years with histologically-confirmed non hematological malignancy that is metastatic or unresectable and for which no standard therapy exists.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
- Peripheral neuropathy less than Grade 2 on National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3 adverse event scale.
- Subjects must have acceptable organ and marrow function during the Screening Period as defined below. (Note: Subjects must meet these criteria at each pre-dose visit to receive additional doses of STA-5312).
- Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or active ischemia as determined by the investigator.
Key exclusion criteria (8 listed)
- Women who are pregnant or breast-feeding.
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Subjects with previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation.
- Subjects with primary brain tumors or active brain metastases are excluded. Subjects with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants are eligible.
- History of stroke within 6 months of treatment or other significant neurological limitations.
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-5312 | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 STA-5312 in people with Advanced or Metastatic Solid Tumors, run by Synta Pharmaceuticals Corp. 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 8 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 3 Feb 2014. 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?
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.
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 3 Feb 2014.