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Non-small Cell Lung Cancer (NSCLC)Phase 2NCT01438307

Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing Cabazitaxel-XRP6258 (3-week cycle) and Cabazitaxel-XRP6258 (5-week cycle) in people with Non-small Cell Lung Cancer (NSCLC) and Stage IV NSCLC, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Cabazitaxel-XRP6258 (3-week cycle) and Cabazitaxel-XRP6258 (5-week cycle)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
Sep 2011to Sep 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified)
  • Subjects who have failed first line chemotherapy (platinum doublets or non- platinum doublets [previous taxane exposure is allowed]) for Stage IV NSCLC.
  • Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Age > 18 years old
  • Adequate bone marrow, liver and renal function, defined as:
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  • Absolute neutrophil count (ANC) greater than or equal to 1500/ul
  • Hemoglobin greater than or equal to 10 g/dl
  • Platelet count greater than or equal to 100,000/ul
  • Total bilirubin less than or equal to 1.5 x upper limit of normal (except in subjects with documented Gilbert's syndrome)
  • AST/ALT less than or equal to 1.5 x upper limit of normal
  • Serum creatinine less than or equal to 1.8 mg/dl
  • Fully recovered from any previous surgery (at least 4 weeks since major surgery)
  • Fully recovered from previous radiation therapy (at least 2 weeks)
  • All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
  • Written informed consent and authorization to use and disclose health information (HIPAA) must be signed by the subject.
  • Subjects with symptomatic brain metastases should be adequately treated and controlled prior to the initiation of the study. Subjects with asymptomatic brain metastases will be allowed in the study without any prior therapy for brain metastases.

Who cannot join

  • Concurrent cancer chemotherapy, biologic therapy or radiotherapy
  • Administration of any investigational agent within 28 days prior to administration of current therapy
  • Untreated symptomatic brain metastases
  • Greater than or equal to Grade 2 neuropathy
  • Concurrent serious infection
  • Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise subject safety and affect the outcome of the study.
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  • Treatment for a cancer other the NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or carcinoma in situ of the cervix
  • Any evidence of history of hypersensitivity for the taxane class of chemotherapy drugs
  • History of positive serology for HIV
  • Psychiatric disorder that prevents subjects from providing informed consent or following protocol instructions
  • Pregnant or lactating women

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Georgia Cancer Center

    Atlanta, Georgia, 30060

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Phase II Study of a Novel Taxane (Cabazitaxel-XRP6258) in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.

Read the detailed description

A substantial number of patients with lung cancer progress after first line treatment and require second line chemotherapy. Lung cancer appears to account for 40-50% of all known brain metastasis. The incidence of brain metastases among lung cancer patients ranges from 16-20%. Chemotherapy has had limited utility due to problems crossing the blood brain barrier.

Currently there are three drugs approved by the FDA for second line treatment of NSCLC but each has distinct toxicities. Cabazitaxel-XRP6258 is a potent novel taxane with enhanced activity against an increased number of cell lines including lung, prostate, colon, pancreas, head and neck, kidney, gastric, glioblastoma, and melanoma. It also has the ability to cross the blood brain barrier. Cabazitaxel-XRP6258 was found to have an improved antiproliferative activity than other chemotherapy agents against insensitive cell lines. The Phase I studies of Cabazitaxel-SRP6258 have determined dosage and schedule recommendations in advanced NSCLC patients to be utilized for a Phase II multicenter study.

Subjects will be placed on one of two schedules (A or B) each with a specified dosage and administration schedule. All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies. A two stage design will be used for each of the two schedules. Fourteen subjects will be accrued for each schedule in the first stage with possible accrual of an additional 34 subjects per schedule depending upon the first stage results.

Being tested
Cabazitaxel-XRP6258 (3-week cycle), Cabazitaxel-XRP6258 (5-week cycle)
Keywords
Non-small cell lung cancer, Cabazitaxel-XRP6258, P-glycoprotein, taxane, Advanced NSCLC
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.

  • Cabazitaxel-XRP6258 (3-week cycle)Drug

    Also called Jevtana

    Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator.

  • Cabazitaxel-XRP6258 (5-week cycle)Drug

    Also called Jevtana

    Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator.

Study groups in NCT01438307
Study groupRoleWhat they receive
Schedule AExperimentalSubjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Receives: Drug: Cabazitaxel-XRP6258 (3-week cycle)
Schedule BExperimentalSubjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.
Receives: Drug: Cabazitaxel-XRP6258 (5-week cycle)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

    Measured: Baseline up to 28 months

Secondary outcomes (3)

  1. Progression Free Survival

    Progression Free Survival is defined from the initiation of treatment until radiological-clinical evidence of progression according to the RECIST (v 1.1).

    Measured: Baseline up to 28 months

  2. Number of Patients With Any Graded Adverse Event

    Safety will be assessed using the National Cancer Institute Common Toxicity Criteria (Version 4.0) and all adverse events will be recorded prior to each treatment regimen.

    Measured: Baseline up to 28 months

  3. Overall Survival

    Assessment will be made in subjects with Stage IV NSCLC who receive Cabazitaxel-SRP6258 after progressing with first line platinum-based chemotherapy.

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2014
  4. Study completionSep 2015

Resources

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
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01438307
Sponsor's protocol ID
F110512012 (UAB 1021)
Other IDs
UAB 1021
Status last verified
Apr 2017
First submitted
15 Sep 2011
Last updated
24 May 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel-XRP6258 (3-week cycle) and Cabazitaxel-XRP6258 (5-week cycle) in people with Non-small Cell Lung Cancer (NSCLC) and Stage IV NSCLC, run by University of Alabama at Birmingham at 2 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 17 inclusion and 11 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (time frame: Baseline up to 28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01438307.

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 24 May 2017.

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