NSCLCPhase 2NCT01852578
Cabazitaxel in Relapsed and Metastatic NSCLC
A Phase 2 study testing Cabazitaxel in people with NSCLC, run by Hellenic Oncology Research Group at 5 sites in Greece.
Trial summary
The investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesGreece
- Study dates
- Sep 2012to Aug 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
- Age>18 years old
- Cytologically or histologically documented NSCLC
- PS 0-2 (WHO scale)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
- Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors with at least one visceral or soft-tissue metastatic lesion.
- Brain metastases are allowed, given that are clinically stable and the patient does not present neurologic symptoms.
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- Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields. Patients who were irradiated to ≥ 40% of bone marrow are not eligible for the study.
- Patients must have a recent (within 7 days prior to treatment start) biochemical and hematogical assessment as defined by adequate bone marrow (absolute neutrophil count ≥1.5 x 109 cells/L, platelets ≥100 x 109cells/L and hemoglobin ≥9 g/dL), liver (AST \& ALT ≤ 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine < 1.5 x ULN). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded) function tests
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Before patient enrollment, written informed consent must be given according to ICH/GCP and national/local regulations.
Who cannot join
- Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy.
- Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial.
- Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix.
- Patient with reproductive potential not implementing accepted and effective method of contraception
- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs or to docetaxel
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus, hypertension, heart failure ≤ NYHA II, history of myocardial infarction within the past 6 months, angina, chronic obstructive pulmonary disease (COPD), serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral)
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- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
- Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment
- Active grade ≥2 peripheral neuropathy
- Active grade ≥2 stomatitis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Greece5 sites
"IASO" General Hospital of Athens Athens, Greece
Athens
Air Forces Military Hospital of Athens Athens, Greece
Athens
"Ag. Georgios" General Hospital of Chania
Chania, Crete
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Crete
"PAPAGEORGIOY" General Hospital of Thessaloniki
Thessaloniki
About this study
Official title: A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment
The investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile.
Read the detailed description
Non small cell lung cancer represents the second most common type of cancer in both men and women in the Western world. The availability of new active regimens in the first line setting has prompted several investigators to consider second line therapy for patients with advanced NSCLC, since a substantial percentage of patients maintain a good PS upon recurrence. On the basis of the results of phase III trials docetaxel, erlotinib, gefitinib, or pemetrexed are considered as "standard" choices for second-line therapy.
However, despite the increased availability of different drugs, NSCLC remains a devastating disease with median OS which rarely exceeds 12 months.
Preclinical data of cabazitaxel have demonstrated antitumor activity in models resistant to paclitaxel and docetaxel. In cell lines resistant to cytotoxic agents, cabazitaxel induced further tumor regression.
The recommended phase 2 doses for Cabazitaxle were 20 and 25 mg/m2. Cabazitaxel showed antitumor activity in solid tumors including docetaxel-refractory metastatic castration-resistant prostate cancer and breast cancer.
- Conditions
- NSCLC
- Being tested
- Cabazitaxel
- Keywords
- Metastatic NSCLC, 2nd Line, Docetaxel-based treatment, Progressed, Refractory
- 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.
CabazitaxelDrug
Also called Jevtana
Cabazitaxel: 25 mg/m² i.v over 1 h on day 1. Cycles repeated ever 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: Disease evaluation at Week 6
Secondary outcomes (4)
Disease control rate
Disease control rate is defined as the proportion of patients with complete response plus partial response plus stable disease
Measured: Disease evaluation at Week 6
Progression Free Survival
Measured: 1 year
Overall Survival
Measured: 1 year
Toxicity profile
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athanasio Kotsakis, MD, Principal investigator, University Hospital of Herklion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852578
- Sponsor's protocol ID
- CT/12.02
- Status last verified
- Sep 2015
- First submitted
- 9 May 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Trial of Cabazitaxel in Patients With Metastatic NSCLC Progressing After Docetaxel-based Treatment
- ClinicalTrials.gov ID
- NCT01852578
- Acronym / sponsor ID
- CT/12.02
- Conditions
- NSCLC
- Keywords
- Metastatic NSCLC, 2nd Line, Docetaxel-based treatment, Progressed, Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 May 2013 (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 investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile.
Detailed description
Non small cell lung cancer represents the second most common type of cancer in both men and women in the Western world. The availability of new active regimens in the first line setting has prompted several investigators to consider second line therapy for patients with advanced NSCLC, since a substantial percentage of patients maintain a good PS upon recurrence. On the basis of the results of phase III trials docetaxel, erlotinib, gefitinib, or pemetrexed are considered as "standard" choices for second-line therapy.
However, despite the increased availability of different drugs, NSCLC remains a devastating disease with median OS which rarely exceeds 12 months.
Preclinical data of cabazitaxel have demonstrated antitumor activity in models resistant to paclitaxel and docetaxel. In cell lines resistant to cytotoxic agents, cabazitaxel induced further tumor regression.
The recommended phase 2 doses for Cabazitaxle were 20 and 25 mg/m2. Cabazitaxel showed antitumor activity in solid tumors including docetaxel-refractory metastatic castration-resistant prostate cancer and breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cabazitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age>18 years old
- Cytologically or histologically documented NSCLC
- PS 0-2 (WHO scale)
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
- Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors with at least one visceral or soft-tissue metastatic lesion.
Key exclusion criteria (10 listed)
- Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy.
- Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial.
- Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix.
- Patient with reproductive potential not implementing accepted and effective method of contraception
- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs or to docetaxel
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 |
|---|---|---|
| CabazitaxelAlso: JevtanaCabazitaxel: 25 mg/m² i.v over 1 h on day 1. Cycles repeated ever 3 weeks | Drug | 1 |
Primary outcome
Overall Response Rate
Time frame: Disease evaluation at Week 6
4 secondary outcomes
Disease control rate
Time frame: Disease evaluation at Week 6
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Toxicity profile
Time frame: Every 3 weeks
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 28 Sep 2015.
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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.
Athanasio Kotsakis, MD principal investigator
University Hospital of Herklion
5 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 Cabazitaxel in people with NSCLC, run by Hellenic Oncology Research Group at 5 sites in Greece.
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 10 inclusion and 10 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece. 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 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?
Overall Response Rate (time frame: Disease evaluation at Week 6). 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 Sep 2015; AzTrials last refreshed its copy on 5 Nov 2026.