Non-small Cell Lung CancerPhase 2NCT00701870
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing ezatiostat hydrochloride (Telintra®) in people with Non-small Cell Lung Cancer, run by Telik at 24 sites in United States.
Trial summary
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel. 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?
- ezatiostat hydrochloride (Telintra®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 24 sitesUnited States
- Study dates
- Oct 2008to Nov 2008
- Phase
- Phase 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
- Histologically confirmed NSCLC
- Stage IIIb-Stage IV NSCLC
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate bone marrow reserve
Who cannot join
- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- Histologically confirmed mixed tumors containing small cell elements
- Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- History of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
- History of HIV
Show all 9Show fewer
- Grade 3 or 4 peripheral neuropathy
- Weightloss greater than 5% within 6 months
- Uncontrolled pleural effusion
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Central Hematology Oncology Medical Group
Alhambra, California, 91801
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
Providence St. Joseph Medical Center
Burbank, California, 91505
Case Medical Center-University Hospitals
Cleveland, Ohio, 44106
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
St. Jude Heritage Healthcare
Fullerton, California, 92835
Medical & Surgical Specialists
Galesburg, Illinois, 61401
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
Nature Coast Clinical Research
Inverness, Florida, 34452
Joliet Oncology/Hematology Associates, Ltd.
Joliet, Illinois, 60435
Wilshire Oncology Medical Group
La Verne, California, 91750
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, 30045
UCLA Medical Center
Los Angeles, California, 90095
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640
Coastal Cancer Center
Myrtle Beach, South Carolina, 29572-4128
North Valley Hematology/Oncology Medical Group
Northridge, California, 91325
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Florida Hospital Cancer Institute
Ormand Beach, Florida, 32174
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Samsum Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
Read the detailed description
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ezatiostat hydrochloride (Telintra®)
- Keywords
- NSCLC, Chemotherapy induced neutropenia, CIN
- 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.
ezatiostat hydrochloride (Telintra®)Drug
Also called Telintra tablets, ezatiostat tablets
4500 mg orally per day in two divided doses
| Study group | Role | What they receive |
|---|---|---|
| ezatiostat hydrochloride (Telintra®) | Experimental | Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery Receives: Drug: ezatiostat hydrochloride (Telintra®) |
| No Intervention | No intervention | Chemotherapy with docetaxel and carboplatin alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of chemotherapy induced neutropenia
Measured: 6 weeks
Secondary outcomes (6)
Duration of chemotherapy induced severe neutropenia
Measured: 6 weeks
Time to ANC recovery from ANC nadir
Measured: 6 weeks
Incidence of febrile neutropenia
Measured: 6 weeks
Incidence of G-CSF administration
Measured: 6 weeks
FACT-N quality of life assessment
Measured: 6 weeks
safety assessments
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Study TLK199.2102 was terminated for lack of enrollment.
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Brown, MD, Study director, Telik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701870
- Sponsor's protocol ID
- TLK199.2102
- Status last verified
- Nov 2013
- First submitted
- 18 Jun 2008
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00701870
- Acronym / sponsor ID
- TLK199.2102
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Chemotherapy induced neutropenia, CIN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study TLK199.2102 was terminated for lack of enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- TelikIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Jun 2008 (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.
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
Detailed description
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ezatiostat hydrochloride (Telintra®) | Experimental | Drug: ezatiostat hydrochloride (Telintra®)Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery |
| No Intervention | No intervention | –Chemotherapy with docetaxel and carboplatin alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed NSCLC
- Stage IIIb-Stage IV NSCLC
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate bone marrow reserve
Key exclusion criteria (9 listed)
- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- Histologically confirmed mixed tumors containing small cell elements
- Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- History of bone marrow transplantation or stem cell support
- Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
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 |
|---|---|---|
| ezatiostat hydrochloride (Telintra®)Also: Telintra tablets, ezatiostat tablets4500 mg orally per day in two divided doses | Drug | ezatiostat hydrochloride (Telintra®) |
Primary outcome
Duration of chemotherapy induced neutropenia
Time frame: 6 weeks
6 secondary outcomes
Duration of chemotherapy induced severe neutropenia
Time frame: 6 weeks
Time to ANC recovery from ANC nadir
Time frame: 6 weeks
Incidence of febrile neutropenia
Time frame: 6 weeks
Incidence of G-CSF administration
Time frame: 6 weeks
FACT-N quality of life assessment
Time frame: 6 weeks
safety assessments
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Study TLK199.2102 was terminated for lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
Gail Brown, MD study director
Telik
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ezatiostat hydrochloride (Telintra®) in people with Non-small Cell Lung Cancer, run by Telik at 24 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 5 inclusion and 9 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 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 stopped early (reason given: Study TLK199.2102 was terminated for lack of enrollment.). 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.
What does the primary outcome measure?
Duration of chemotherapy induced neutropenia (time frame: 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 27 Nov 2013.