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CompletedPhase 2NCT01438307
Official study title

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

Study 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. 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCabazitaxel-XRP6258 (3-week cycle) and Cabazitaxel-XRP6258 (5-week cycle)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 24, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Alabama at Birmingham

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Alabama at Birmingham
Interventions being studied
Drug: Cabazitaxel-XRP6258 (3-week cycle); Drug: Cabazitaxel-XRP6258 (5-week cycle)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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:
  • 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.
Reasons someone may not be able to joinExclusion criteria
  • 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.
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • Georgia Cancer CenterAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 24, 2017. Always confirm current availability with the study team.

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