Non-small Cell Lung CancerPhase 1/2NCT00077883
TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing TLK286, cisplatin in people with Non-small Cell Lung Cancer, run by Telik at 3 sites in United States.
Trial summary
The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- TLK286, cisplatin
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2004to Mar 2007
- 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
- 18 years of age or older
- Histologically confirmed non-small cell lung cancer
- Stage IV or IIIB
- Measurable disease by RECIST
- ECOG performance status of 0-1
- Adequate liver and renal function
- Adequate bone marrow reserve
Who cannot join
- History of bone marrow transplantation or stem cell support
- Pregnant or lactating women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Univ. of MD, Greenbaum Cancer Center
Baltimore, Maryland, 21201
Univ. of TX, MD Anderson Cancer Center
Houston, Texas, 77030
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
About this study
Official title: Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- TLK286, cisplatin
- 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.
TLK286, cisplatinDrug
TLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days).
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objectives of the Study
- To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
- To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionMar 2007
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077883
- Sponsor's protocol ID
- TLK286.2021
- Status last verified
- Jun 2005
- First submitted
- 12 Feb 2004
- Last updated
- 25 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00077883
- Acronym / sponsor ID
- TLK286.2021
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Feb 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 trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.
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)
- 18 years of age or older
- Histologically confirmed non-small cell lung cancer
- Stage IV or IIIB
- Measurable disease by RECIST
- ECOG performance status of 0-1
Key exclusion criteria (2 listed)
- History of bone marrow transplantation or stem cell support
- Pregnant or lactating women
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 |
|---|---|---|
| TLK286, cisplatinTLK286 administered once every 3 weeks (± 2 days) at two dose-ranging levels (750 mg/m²) and 1,000 mg/²) in combination with two dose levels of cisplatin (75 mg/m² and 100 mg/m²) of cisplatin once every 3 weeks (± 2 days). | Drug | – |
Primary outcome
Primary Objectives of the Study
Time frame: Every 3 weeks
1. To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 2. To determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
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 25 Jul 2011.
- Related InfoLink 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLK286, cisplatin in people with Non-small Cell Lung Cancer, run by Telik 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 2 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 25 Jul 2011. 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 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 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.
What does the primary outcome measure?
Primary Objectives of the Study (time frame: Every 3 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 25 Jul 2011.