Small Cell Lung CancerPhase 2NCT02262897
The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer
A Phase 2 study testing Nab-paclitaxel in people with Small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial summary
Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to May 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain of informed consent.
- Male or female aged 18 years and over.
- Histologically or cytologically confirmed small cell lung carcinoma.
- Extensive disease before receive nab-paclitaxel.
- Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed.
- World Health Organization (WHO) performance status (PS) of 0 to 2.
Show all 14Show fewer
- Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
- Heart index values is in the range, as defined below, within two weeks of randomization:
- Absolute neutrophils count(ANC)≥2.0×109/L
- Platelets≥100×109/L
- Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases)
- Creatinine clearance≥60ml/min
- Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
- Life expectancy ≥12 weeks.
Who cannot join
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy.
- Prior treatment with paclitaxel.
- Pregnant or lactating woman.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Life expectancy of less than 12 weeks.
Trial locations and contacts
1 site in 1 country.
Shengxiang Ren contact
Caicun Zhou contact
China1 site, 1 recruiting
- Recruiting
Shengxiang Ren
Shanghai, 200433
Shengxiang Ren, harry_ren@126.com
Guanghui Gao, ghgao103@hotmail.com
About this study
Official title: Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy
Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).
As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.
Read the detailed description
Primary end point: Objective Response Rate(ORR)
Secondary end point:
Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Nab-paclitaxel
- Keywords
- small cell lung cancer, chemotherapy, Nab-paclitaxel
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Albumin-bound paclitaxel， Abraxane
Nab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel single agent | Experimental | Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy
Measured: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
Secondary outcomes (4)
Progression free survival
PFS is evaluated in the 24 months since the treatment began
Measured: 24 months
overall survival
evaluated in the 24th month since the treatment began
Measured: 24 months
Side effects
evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: 24 months
Quality Of Life
evaluated in the 24th month since the treatment began
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- Guanghui Gao, Study chair, Tongji University Affiliated Shanghai Pulmonary HospitalChunxia Su, Study chair, Tongji University Affiliated Shanghai Pulmonary HospitalXiaoxia Chen, Study chair, Tongji University Affiliated Shanghai Pulmonary HospitalWei Li, Study chair, Tongji University Affiliated Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262897
- Sponsor's protocol ID
- FK1401
- Status last verified
- Oct 2014
- First submitted
- 23 Sep 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy
- ClinicalTrials.gov ID
- NCT02262897
- Acronym / sponsor ID
- FK1401
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, chemotherapy, Nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Oct 2014 (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.
Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).
As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.
Detailed description
Primary end point: Objective Response Rate(ORR)
Secondary end point:
Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel single agent | Experimental | Drug: Nab-paclitaxelNab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Obtain of informed consent.
- Male or female aged 18 years and over.
- Histologically or cytologically confirmed small cell lung carcinoma.
- Extensive disease before receive nab-paclitaxel.
- Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed.
Key exclusion criteria (7 listed)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy.
- Prior treatment with paclitaxel.
- Pregnant or lactating woman.
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 |
|---|---|---|
| Nab-paclitaxelAlso: Albumin-bound paclitaxel， AbraxaneNab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks | Drug | Nab-paclitaxel single agent |
Primary outcome
Objective Response Rate
Time frame: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy
4 secondary outcomes
Progression free survival
Time frame: 24 months
overall survival
Time frame: 24 months
Side effects
Time frame: 24 months
Quality Of Life
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Shengxiang Ren contact
Caicun Zhou contact
Guanghui Gao study chair
Tongji University Affiliated Shanghai Pulmonary Hospital
Chunxia Su study chair
Tongji University Affiliated Shanghai Pulmonary Hospital
Xiaoxia Chen study chair
Tongji University Affiliated Shanghai Pulmonary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel in people with Small Cell Lung Cancer, run by Tongji University at 1 site in China.
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 14 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengxiang Ren (harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months). 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 13 Oct 2014.