Non-small Cell Lung CancerPhase 1/2NSCLCNCT01234038
Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Carboplatin and Paclitaxel
A Phase 1/2 study testing ISIS EIF4E Rx, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Ionis Pharmaceuticals, Inc. at 29 sites in 4 countries.
Trial summary
The purpose of this study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel. 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?
- ISIS EIF4E Rx, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 29 sitesin 4 countries
- Study dates
- Nov 2010to Jan 2013
- 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
- Male or female patients age >/= 18 years
- Histologically or cytologically confirmed diagnosis of NSCLC
- Stage IV disease (including patients with pleural effusion who were previously classified as Stage IIIB)
- All of the following if patient has had prior radiation therapy:
- Lesion(s) used for determination of response were not previously irradiated or have increased in size since the completion of radiotherapy
- The patient has recovered from any acute effects of the radiotherapy
Show all 24Show fewer
- Radiotherapy was completed at least 4 weeks prior to Screening
- Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)
- Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension
- Performance status of 0 or 1 on the ECOG Performance Status Scale
- Have an estimated life expectancy of at least 12 weeks
- Adequate organ function within 14 days prior to first study dose (ISIS EIF4E Rx or carboplatin/paclitaxel, whichever occurs first) as defined by:
- Absolute neutrophil count (ANC) >/= 1.5 x 109/L
- Platelet count >/= 100 x 109/L
- Hemoglobin >/=9 g/dL (>/= 5.6 mmol/L). Patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator.
- Total bilirubin < 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert's Disease
- Aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)
- Alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)
- Alkaline phosphatase < 3.0 x ULN
- Calculated creatinine clearance >/= 60 mL/min per Cockcroft and Gault formula
- Satisfy one of the following:
- Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or patient or partner compliant with a reliable contraceptive regimen, as determined by Investigator, for 4 weeks prior to Screening. Patients of reproductive potential must test negative for pregnancy at Screen and must agree to use a reliable method of birth control during the study and for the 10 weeks following the last dose of ISIS EIF4E Rx.
- Males: surgically sterile or patient or partner must agree to use a reliable contraceptive method, as determined by the Investigator during the study and for the 10 weeks following the last dose of ISIS EIF4E Rx.
- For Part 1: have discontinued all prior chemotherapies, biological therapies, and other investigational therapies for cancer for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study treatment and recovered from the acute effects of therapy.
Who cannot join
- Part 1: More than 2 prior chemotherapy or biological therapy regimens (approved or experimental) for NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of treatment.
- Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant and neoadjuvant treatments
- Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before Screening or 5 half-lives of study agent, whichever is longer
- Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Patients with known pericardial effusion
- Have active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
Show all 15Show fewer
- Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies were diagnosed and definitively treated at least five years previously with no subsequent evidence of recurrence.
- Presence of an underlying disease state associated with active bleeding
- Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin/coumadin). Low-dose anticoagulants for maintenance of catheter patency and low dose aspirin (≤ 325 mg/day) and nonsteroidal anti-inflammatory agents are not exclusionary.
- Concurrent treatment with other anticancer drugs
- Pre-existing peripheral neuropathy >/=Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) Grade 2
- Known history of HIV, HCV, or chronic HBV infection
- Previous treatment with a therapeutic antisense oligonucleotide or siRNA
- Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
- Have any other medical conditions that in the opinion of the Investigator, would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
United States10 sites
Achieve Clinical Research
Birmingham, Alabama, 35216
Gabrail Cancer Center
Canton, Ohio, 44718
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Joliet Hematology Oncology Associates
Joliet, Illinois, 60435
Little Rock Cancer Clinic
Little Rock, Arkansas, 72205
Kenmar Research Institute
Los Angeles, California, 90057
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Jewish Hospital & St. Mary's Healthcare
Louisville, Kentucky, 40245
Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Russia9 sites
State Medical Institution: Arkhangelsk Regional Clinical Oncology Center, Chemotherapy department
Arkhangelsk, 163045
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Clinical Oncology Center, Chemotherapy Department
Chelyabinsk, 454087
State Healthcare Institution: Ivanovo Regional Oncology Center, Chemotherapy Department
Ivanovo, 153013
Non-State Medical Institution: Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC Russian Railways, Chemotherapy Dept.
Moscow, 129128
State Healthcare Institution: Leningrad Regional Clinical Hospital, Thoracic Surgery Department
Saint Petersburg, 194291
St. Petersburg State Healthcare Institution: "City Clinical Oncology Center"
Saint Petersburg, 197022
State Higher Educational Institution: St. Petersburg State Medica University n.a.I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Pulmonology Research Institute
Saint Petersburg, 197101
State Institution: Samara Regional Clinical Oncology Center, Chemotherapy Department
Samara, 443031
State Budget Healthcare Institution: Sverdlovsk Regional Oncology Center, Radiotherapy Department
Yekaterinburg, 620036
Hungary5 sites
Koranyi National Institute of TBC and Pulmonology
Budapest, H-1121
Semmelweis University Faculty of Medicine
Budapest, H-1125
University of Debrecen, Medical and Health Science Center
Debrecen, H-4032
Hospital for Thoracic Diseases of Csongrad County Local Governmental
Deszk, H-6772
Bekes Country Pandy Kalman Hospital
Gyula, H-5703
Poland5 sites
K. Dluski Provincial Specialist Hospital
Bialystok, 15-540
Independent Public Teaching Hospital No. 4 In Lublin
Lublin, 20-954
Idependent Public Tuberculosis an Lung Diseases Facilities
Olsztyn, 10-357
Specialist Tuberculosis and Lung Diseases Hospitals
Rzeszów, 35-241
Alojzy Pawelec Provincial Hospital of Lung Diseases
Wodzisław Śląski, 44-300
About this study
Official title: A Phase 1b/2 Study of Carboplatin-Paclitaxel, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Stage IV Non-Small Cell Lung Cancer
The purpose of this study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ISIS EIF4E Rx, Paclitaxel, Carboplatin
- 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.
ISIS EIF4E RxDrug
800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
ISIS EIF4E RxDrug
1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
ISIS EIF4E RxDrug
(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8, and 15 of each 21 day cycle
PaclitaxelDrug
200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle
CarboplatinDrug
AUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Not described Receives: Drug: ISIS EIF4E Rx; Drug: Paclitaxel; Drug: Carboplatin |
| Part 1 Cohort 2 | Experimental | Not described Receives: Drug: ISIS EIF4E Rx; Drug: Paclitaxel; Drug: Carboplatin |
| Part 2 Arm A | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Carboplatin |
| Part 2 Arm B | Experimental | Not described Receives: Drug: ISIS EIF4E Rx; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: At the end of each 21 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionJan 2013
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.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234038
- Sponsor's protocol ID
- ISIS 183750-CS4
- Acronym
- NSCLC
- Status last verified
- Jun 2018
- First submitted
- 2 Nov 2010
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of Carboplatin-Paclitaxel, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Stage IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01234038
- Acronym / sponsor ID
- NSCLC / ISIS 183750-CS4
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Nov 2010 (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 study is to examine the overall survival of patients with Stage IV non-small cell lung cancer (NSCLC) treated with ISIS EIF4E Rx in combination with carboplatin and paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Drug: ISIS EIF4E Rx, Drug: Paclitaxel, Drug: Carboplatin |
| Part 1 Cohort 2 | Experimental | Drug: ISIS EIF4E Rx, Drug: Paclitaxel, Drug: Carboplatin |
| Part 2 Arm A | Experimental | Drug: Paclitaxel, Drug: Carboplatin |
| Part 2 Arm B | Experimental | Drug: ISIS EIF4E Rx, Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female patients age >/= 18 years
- Histologically or cytologically confirmed diagnosis of NSCLC
- Stage IV disease (including patients with pleural effusion who were previously classified as Stage IIIB)
- All of the following if patient has had prior radiation therapy:
- Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)
Key exclusion criteria (15 listed)
- Part 1: More than 2 prior chemotherapy or biological therapy regimens (approved or experimental) for NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive cycles of treatment.
- Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant and neoadjuvant treatments
- Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before Screening or 5 half-lives of study agent, whichever is longer
- Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Patients with known pericardial effusion
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 |
|---|---|---|
| ISIS EIF4E Rx800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle | Drug | Part 1 Cohort 1 |
| ISIS EIF4E Rx1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle | Drug | Part 1 Cohort 2 |
| ISIS EIF4E Rx(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8, and 15 of each 21 day cycle | Drug | Part 2 Arm B |
| Paclitaxel200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle | Drug | Part 1 Cohort 1, Part 1 Cohort 2, Part 2 Arm A, Part 2 Arm B |
| CarboplatinAUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle | Drug | Part 1 Cohort 1, Part 1 Cohort 2, Part 2 Arm A, Part 2 Arm B |
Primary outcome
Progression free survival
Time frame: At the end of each 21 day cycle
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 27 Jun 2018.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
RecruitingPhase 2
Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial
Nsclc, NSCLC Stage II
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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.
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ISIS EIF4E Rx, Paclitaxel and Carboplatin in people with Non-small Cell Lung Cancer, run by Ionis Pharmaceuticals, Inc. at 29 sites in 4 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 24 inclusion and 15 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Russia, Hungary, Poland. 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?
Progression free survival (time frame: At the end of each 21 day cycle). 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 Jun 2018.