Carcinoma, Non-Small-Cell LungPhase 1/2NCT00088556
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing TLK286, carboplatin and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Telik at 52 sites in United States.
Trial summary
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- TLK286, carboplatin and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 52 sitesUnited States
- Study dates
- Aug 2004to May 2009
- 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 (NSCLC)
- Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
- Measurable disease by RECIST
- ECOG status of 0-1
- Adequate liver and renal function
- Adequate bone marrow reserves
Who cannot join
- Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
- Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
- History of bone marrow transplantation or stem cell support
- Pregnant or lactating women
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
University of Maryland, Baltimore University of Maryland Medical System-Greenebaum Cancer Center
Baltimore, Maryland, 21201
Center for Cancer and Blood Disorders, P. C.
Bethesda, Maryland, 20817
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Tennessee Oncology, PLLC
Clarksville, Tennessee, 37043
Bay Area Cancer Research Group
Concord, California, 94520
East Bay Medical Oncology/Hematology Associates
Concord, California, 94520
Citrus Hematology and Oncology
Crystal River, Florida, 34429
Texas Cancer Associates
Dallas, Texas, 75231
Danville Hematology & Oncology, Inc.
Danville, Virginia, 24541
Southwest Cancer Care
Escondido, California, 92025
Dakota Cancer Institute
Fargo, North Dakota, 58103
Odyssey Research
Fargo, North Dakota, 58104
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067
Kaiser Permanente Medical Center
Hayward, California, 94545
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076
Citrus Hematology and Oncology Center
Inverness, Florida, 34452
Florida Wellcare Alliance, LC
Inverness, Florida, 34452
Kansas City Cancer Center
Kansas City, Kansas, 66112
Kansas City Cancer Center
Kansas City, Missouri, 64111
Kansas City Cancer Center
Kansas City, Missouri, 64131
Kansas City Cancer Center
Kansas City, Missouri, 64154
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087
Kansas City Cancer Center
Lee's Summit, Missouri, 64064
Kansas City Cancer Center - Central Research Dept. Data Office & Drug Discovery Location
Lenexa, Kansas, 66214
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130
Southwest Cancer Care
Murrieta, California, 92562
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211
Kaiser Permanente Medical Center
Oakland, California, 94611
Kansas City Cancer Center
Overland Park, Kansas, 66210
Texas Cancer Associates
Plano, Texas, 75093
Southwest Cancer Care
Poway, California, 92064
Kaiser Permanente Medical Center
Sacramento, California, 95825
Kaiser Permanente Medical Center
San Francisco, California, 94115
Kaiser Permanente Medical Center
San Jose, California, 95119
Kaiser Permanente Medical Center
Santa Clara, California, 95051
Clinical Research Service
Scottsbluff, Nebraska, 69361
Horizons West Medical Group
Scottsbluff, Nebraska, 69361
Department of Veterns Affairs - Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167
Kaiser Permanente Medical Center
So. San Francisco, California, 94080
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Kaiser Permanente Medical Center
Vallejo, California, 94589
Diablo Valley Oncology & Hematology Medical Group
Walnut Creek, California, 94520
Kaiser Permanente Medical Center
Walnut Creek, California, 94596
St. John's Mercy Hospital
Washington, Missouri, 63090
About this study
Official title: Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- TLK286, carboplatin, paclitaxel
- Keywords
- Non-small cell lung cancer
- 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.
TLK286Drug
Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
carboplatinDrug
AUC 6 mg/mL/min Once every 3 weeks
paclitaxelDrug
200 mg/m² Once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Triplet Combination of TLK286 Carboplatin & Paclitaxel | Experimental | Experimental Receives: Drug: TLK286; Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Objectives
- To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
- To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
- To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
Measured: Every 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2004 (estimated)
- Study startAug 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088556
- Sponsor's protocol ID
- TLK286.2023
- Status last verified
- Jun 2011
- First submitted
- 29 Jul 2004
- Last updated
- 31 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00088556
- Acronym / sponsor ID
- TLK286.2023
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 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 trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triplet Combination of TLK286 Carboplatin & Paclitaxel | Experimental | Drug: TLK286, Drug: carboplatin, Drug: paclitaxelExperimental |
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 (NSCLC)
- Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
- Measurable disease by RECIST
- ECOG status of 0-1
Key exclusion criteria (4 listed)
- Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
- Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
- 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 |
|---|---|---|
| TLK286Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m² | Drug | Triplet Combination of TLK286 Carboplatin & Paclitaxel |
| carboplatinAUC 6 mg/mL/min Once every 3 weeks | Drug | Triplet Combination of TLK286 Carboplatin & Paclitaxel |
| paclitaxel200 mg/m² Once every 3 weeks | Drug | Triplet Combination of TLK286 Carboplatin & Paclitaxel |
Primary outcome
Study Objectives
Time frame: Every 6 Weeks
1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
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 31 May 2012.
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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.
52 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, carboplatin and paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Telik at 52 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 4 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 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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?
Study Objectives (time frame: Every 6 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 31 May 2012.