Non-Small-Cell Lung CarcinomaPhase 1/2NCT00112060
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing PT-523 for Injection in people with Non-Small-Cell Lung Carcinoma, run by Spectrum Pharmaceuticals, Inc at 13 sites in 2 countries.
Trial summary
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- PT-523 for Injection
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2008to Sep 2011
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years
- Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).
- Asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
- Use of appropriate contraceptive method.
- Signed patient informed consent.
Who cannot join
- Investigational agents within 30 days prior to Day 1 of study.
- Known symptomatic or uncontrolled brain metastases.
- Uncontrolled intercurrent illness.
- Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.
- Patient has uncontrolled pleural effusions.
- Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Russia9 sites
Chelyabinsk Regional Oncology Center Chemotherapy Department
Chelyabinsk, 454087
Irkutsk Regional Oncology Center
Irkutsk, 664035
Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia
Moscow, 115478
Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy
Moscow, 115478
Semashko Central Clinical Hospital
Moscow, 129128
St. Petersburg Pavlov State Medical University
Saint Petersburg, 197022
Petrov Research Institute of Oncology
Saint Petersburg, 197758
St. Petersburg Oncology Center Thoracic Department
Saint Petersburg, 198255
Yaroslavl City Oncology Center
Yaroslavl, 150054
United States4 sites
University of Chicago
Chicago, Illinois, 60637-1470
Case Western Reserve University & University Hospitals of Cleveland
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
University of Miami and Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- PT-523 for Injection
- Keywords
- Talotrexin, PT-523, Non-Small Cell Lung Carcinoma (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 posted30 May 2005 (estimated)
- Study startApr 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112060
- Sponsor's protocol ID
- HBS101
- Other IDs
- HBS101.00
- Status last verified
- Mar 2014
- First submitted
- 27 May 2005
- 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/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00112060
- Acronym / sponsor ID
- HBS101
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Talotrexin, PT-523, Non-Small Cell Lung Carcinoma (NSCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 May 2005 (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.
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.
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)
- Age ≥ 18 years
- Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).
- Asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
- ECOG performance status 0 - 2.
- Adequate organ function and bone marrow reserve.
Key exclusion criteria (6 listed)
- Investigational agents within 30 days prior to Day 1 of study.
- Known symptomatic or uncontrolled brain metastases.
- Uncontrolled intercurrent illness.
- Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.
- Patient has uncontrolled pleural effusions.
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 withdrawn before enrolling participants, so there are no results.
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PT-523 for Injection in people with Non-Small-Cell Lung Carcinoma, run by Spectrum Pharmaceuticals, Inc at 13 sites in 2 countries.
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 6 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: withdrawn, 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 13 sites in Russia, 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.