NeoplasmsPhase 1NCT00088023
Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness
A Phase 1 study testing PT-523 for Injection in people with Neoplasms, run by Spectrum Pharmaceuticals, Inc at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- PT-523 for Injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2004to Dec 2005
- 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
- Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
- Age greater than or equal to 18 years.
- Life expectancy greater than or equal to 2 months.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- Use of appropriate contraceptive method.
- Sign patient informed consent.
Who cannot join
- Active brain metastases.
- Presence of third-space fluid collections (pleural effusion, ascites).
- Major surgery within 3 weeks prior to dosing.
- Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
- Prior bone marrow transplantation.
- Presence of uncontrolled serious medical or psychiatric illness.
- Patients requiring radiation therapy.
- There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Study of PT-523 in Patients With Solid Tumors
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.
Read the detailed description
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
- Conditions
- Neoplasms
- Being tested
- PT-523 for Injection
- Keywords
- Solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-523 for InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2004 (estimated)
- Study startMar 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Joseph Paul Eder, M.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088023
- Sponsor's protocol ID
- 02-000
- Other IDs
- DFCI Legacy- 03-183, CTEP Grant No.- UO1-CA62490-09, NSC No.- 712783
- Status last verified
- Mar 2014
- First submitted
- 19 Jul 2004
- Last updated
- 31 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of PT-523 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00088023
- Acronym / sponsor ID
- 02-000
- Conditions
- Neoplasms
- Keywords
- Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Study completion
- Dec 2005
- First posted
- 20 Jul 2004 (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 study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.
Detailed description
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
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 (7 listed)
- Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
- Age greater than or equal to 18 years.
- Life expectancy greater than or equal to 2 months.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
Key exclusion criteria (8 listed)
- Active brain metastases.
- Presence of third-space fluid collections (pleural effusion, ascites).
- Major surgery within 3 weeks prior to dosing.
- Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
- Prior bone marrow transplantation.
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 |
|---|---|---|
| PT-523 for Injection | Drug | – |
Primary outcome
Not reported in the source record.
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 31 Mar 2014.
- Hana Biosciences, Inc. is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care.Link 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.
Joseph Paul Eder, M.D. principal investigator
Dana-Farber Cancer Institute
3 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 PT-523 for Injection in people with Neoplasms, run by Spectrum Pharmaceuticals, Inc at 3 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 7 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: stopped early, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 31 Mar 2014.