Stage IIIB Non-small Cell Lung Cancer With Pleural EffusionPhase 2NCT01337154
First Line Study of Tamibarotene in Combination for Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Tamibarotene in people with Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion and Stage IV Non-small Cell Lung Cancer, run by CytRx at 26 sites in 6 countries.
Trial summary
The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- Tamibarotene
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Apr 2011to Jun 2013
- 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
- Subjects must be at least 18 years of age
- Subjects must have pathological findings consistent with primary non-small cell lung cancer of any histology.
- Subjects must have either stage IIIB with pleural effusion or IV NSCLC with radiographically measurable disease (RECIST 1.1 criteria). Women non-smokers with stage IV NSCLC should be screened for EGFR mutation and if positive be excluded from the study and placed on an EGFR kinase inhibitor.
- Subjects must have an ECOG Performance Status ≤2.
- If corticosteroids are required for controlling cerebral edema, subjects must be on a stable dose for at least 1 week.
- Subjects must have recovered from any toxicity of prior therapies.
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- Subjects must be at least 4 weeks removed from surgery or radiation therapy.
- Subjects must have a life expectancy of at least 12 weeks.
- Subjects must have adequate bone marrow function (defined as an absolute neutrophil count of ≥1500 cells/mm3 and platelet count ≥100,000 cells/mm3), liver function with total bilirubin ≤2.0 mg/dL, and serum creatinine ≤1.5 x institutional ULN.
- Subjects must be able to understand and be willing to sign a written informed consent document.
- Tamibarotene, as with all retinoids, is teratogenic. Therefore, female subjects of childbearing potential must agree to use 2 effective methods of contraception (hormonal, barrier method of birth control, or abstinence) and sexually-active male subjects must agree to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) while participating in this study and for six months afterwards. Women of childbearing potential must have a negative pregnancy test ≤1 week prior to registration.
- Subjects must be able to swallow tablets.
- If available, tumor specimens must be submitted for immunohistochemistry analyses with their pathology reports.
Who cannot join
- Subjects who have received or are currently receiving chemotherapy or antibody therapy, or are enrolled in another treatment clinical trial.
- Subjects with a coagulopathy or bleeding disorder.
- Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris (i.e. myocardial infarction with 6 months prior to enrollment, uncontrolled angina, electrocardiographic evidence of acute ischemia).
- Subjects who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study.
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- HIV-positive subjects; however, subjects will not be routinely screened for HIV.
- Subjects who are allergic to any of the intended chemotherapies.
- Female subjects who are pregnant or breast-feeding.
- Active, clinically significant serious infection requiring treatment with antibiotics, antivirals, or antifungals.
- Subjects with peripheral neuropathy ≥grade 2
- Prior systemic treatment for locally advanced or metastatic disease (exception below): Prior adjuvant chemotherapy for Stage I-III or combined modality chemotherapy-radiation for locally advanced disease allowed if completed >12 months prior to randomization.
- Subjects with brain metastases are only eligible if treated and neurologically stable with no ongoing requirement for corticosteroids, e.g., dexamethasone, for at least 2 weeks.
- Subjects with hypertriglyceridemia (>1000 mg/dL).
- Subjects with elevated liver function tests if AST is ≥2.5x the institutional or central laboratory's upper limit of normal for subjects without liver metastases, or >5x the institutional or central laboratory's upper limit of normal for subjects with liver metastases.
- Subjects with HbA1c ≥8.0.
- Subjects taking vitamin A either as a supplement or as part of a multivitamin unless there has been at least a 2 week washout.
- Subjects using concomitant medications that are known inducers or inhibitors of CYP3A4 up to 14 days before Cycle 1 Day 1 (pimozide, diltiazem, erythromycin, clarithromycin, and quinidine, and amiodarone) should be excluded from the study.
- Subjects whose tumors cannot be adequately measured per RECIST 1.1.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
India8 sites
M S Patel Cancer Centre, Shree Krishna Hospital
Anand, Gujarat, 388 325
Dr. Kamakshi Memorial Hospital
Chennai, Pallikaranai, 600100
G Kuppuswamy Naidu Memorial Hospital, Valvadi Narayanaswamy Cancer Centre
Coimbatore, Pappanaickenpalayam, 641037
NIZAM's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082
Orchid Nursing Home
Kolkata, West Bengal, 700054
Curie Manavata Cancer Centre
Nashik, Maharashtra, 411013
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, 422 005
Noble Hospital
Pune, Maharashtra, 411013
Ukraine6 sites
Public Institution: Dnipropetrovsk City Multispeciality Clinical Hospital #4
Dnipropetrovsk, 49102
Public Clinical Treatment and Prophylaxis Instituion: Donetsk Regional Antitumor Center
Donetsk, 83092
Ivano-Frankivsk Regional Oncology Center
Ivano-Frankivsk, 76018
Public Healthcare Instituion: Kharkiv Regional Clinical Oncology Center
Kharkiv, 61070
Kyiv City Clinical Oncology Center
Kyiv, 03115
Zakarpattia Regional Clinical Oncology Center
Uzhhorod, 88014
Russia5 sites
State Medical Institution: Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, 163045
State Therapeutical and Prophylatic Institution: Chelyabinsk Regional Clinical Oncology Center
Chelyabinsk, 454087
State Medical Instituion Kursk Regional Oncology Center
Kursk, 305035
Non-State Medical Institution: Central Clinical Hospital #2
Moscow, 129128
St. Petersburg State Healthcare Institution: City Clinical Oncology Center
Saint-Pertersburg, 197022
United States3 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Kansas City Cancer Center
Kansas City, Kansas, 66112
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
Bulgaria3 sites
Department of Medical Oncology, Specialized Hospital for Active Treatment of Oncological Diseases
Sofia, 1233
Medical Oncology Clinic, Multiprofile Hospital for Active Treatment
Varna, 9010
Department of Medical Oncology, Complex Oncology Center
Veliko Tarnovo, 5000
About this study
Official title: A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects With Advanced Non-Small Cell Lung Cancer
The goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as twice daily orally, or an equal number of matching placebo tablets, starting 1 week before chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Conditions
- Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion, Stage IV Non-small Cell Lung Cancer
- Being tested
- Tamibarotene, Placebo
- Keywords
- NSCLC, non-small cell lung cancer, tamibarotene
- 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.
TamibaroteneDrug
Tablet, 6 mg/m2, oral, divided into twice a day dosing.
PlaceboDrug
Tablets, orally, daily
| Study group | Role | What they receive |
|---|---|---|
| Tamibarotene | Experimental | Subjects will receive tamibarotene, 6 mg/m2, divided as twice daily orally starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Chemotherapy will include paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6)administered once every 3 weeks for up to 6 cycles. Receives: Drug: Tamibarotene |
| Placebo | Placebo comparator | Subjects will take an equal number of placebo tablets as the group receiving tamibarotene divided as twice daily orally, starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6) will be administered once every 3 weeks for up to 6 cycles. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) is defined as the time from enrollment (i.e., assignment of subject ID number) to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
Measured: Within 18 months of study start.
Secondary outcomes (3)
Objective response rate
Objective tumor response will be evaluated using the RECIST 1.1 criteria.
Measured: Within 18 months of study start.
Overall survival
Measured: Within 24 months of study start.
Assessment of quality of life
EORTC QLQ-C30 version 3.
Measured: Within 24 months of study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Interim analysis showed that the primary endpoint would not be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Non-small Cell Lung Cancer With Pleural EffusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Arrieta, M.D., Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337154
- Sponsor's protocol ID
- TAMI-P2-NSCLC-01
- Status last verified
- Jun 2013
- First submitted
- 15 Apr 2011
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Phase 2b Study of Tamibarotene Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin as First Line Treatment for Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01337154
- Acronym / sponsor ID
- TAMI-P2-NSCLC-01
- Conditions
- Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion, Stage IV Non-small Cell Lung Cancer
- Keywords
- NSCLC, non-small cell lung cancer, tamibarotene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed that the primary endpoint would not be met.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- CytRxIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Apr 2011 (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 goal of this study is to determine the progression-free survival and objective response rate in subjects with either stage IIIB with pleural effusion NSCLC or stage IV NSCLC who are treated with up to six cycles of paclitaxel plus carboplatin and either tamibarotene or placebo. Subjects will be randomly assigned to receive tamibarotene, 6 mg/m2, divided as twice daily orally, or an equal number of matching placebo tablets, starting 1 week before chemotherapy and continuing through all 6 cycles and beyond. Subjects will be assessed for response on Day 50, Day 113, then every other month using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamibarotene | Experimental | Drug: TamibaroteneSubjects will receive tamibarotene, 6 mg/m2, divided as twice daily orally starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Chemotherapy will include paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6)administered once every 3 weeks for up to 6 cycles. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take an equal number of placebo tablets as the group receiving tamibarotene divided as twice daily orally, starting 1 week before chemotherapy and continuing through all 6 cycles and through the duration of the study. Paclitaxel (IV; 200 mg/m2) and carboplatin (IV; AUC=6) will be administered once every 3 weeks for up to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must be at least 18 years of age
- Subjects must have pathological findings consistent with primary non-small cell lung cancer of any histology.
- Subjects must have either stage IIIB with pleural effusion or IV NSCLC with radiographically measurable disease (RECIST 1.1 criteria). Women non-smokers with stage IV NSCLC should be screened for EGFR mutation and if positive be excluded from the study and placed on an EGFR kinase inhibitor.
- Subjects must have an ECOG Performance Status ≤2.
- If corticosteroids are required for controlling cerebral edema, subjects must be on a stable dose for at least 1 week.
Key exclusion criteria (19 listed)
- Subjects who have received or are currently receiving chemotherapy or antibody therapy, or are enrolled in another treatment clinical trial.
- Subjects with a coagulopathy or bleeding disorder.
- Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris (i.e. myocardial infarction with 6 months prior to enrollment, uncontrolled angina, electrocardiographic evidence of acute ischemia).
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 |
|---|---|---|
| TamibaroteneTablet, 6 mg/m2, oral, divided into twice a day dosing. | Drug | Tamibarotene |
| PlaceboTablets, orally, daily | Drug | Placebo |
Primary outcome
Progression-free survival
Time frame: Within 18 months of study start.
Progression-free survival (PFS) is defined as the time from enrollment (i.e., assignment of subject ID number) to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
3 secondary outcomes
Objective response rate
Time frame: Within 18 months of study start.
Overall survival
Time frame: Within 24 months of study start.
Assessment of quality of life
Time frame: Within 24 months of study start.
Results and safety
The study was stopped early (reason given: Interim analysis showed that the primary endpoint would not be met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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.
Oscar Arrieta, M.D. principal investigator
Instituto Nacional de Cancerologia, Columbia
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamibarotene in people with Stage IIIB Non-small Cell Lung Cancer With Pleural Effusion and Stage IV Non-small Cell Lung Cancer, run by CytRx at 26 sites in 6 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 13 inclusion and 19 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 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in India, Ukraine, Russia, United States, Bulgaria and 1 more country. 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. Some participants in this study may receive a placebo. 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: Interim analysis showed that the primary endpoint would not be met.). 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?
Progression-free survival (time frame: Within 18 months of study start.). 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 28 Jun 2013.