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

NCT01438307 | Completed Phase 2 Results DMC

• 2 other identifiers: F110512012 (UAB 1021)UAB 1021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC); Stage IV NSCLC; Metastatic NSCLC

Keywords

Non-small cell lung cancer; Cabazitaxel-XRP6258; P-glycoprotein; taxane; Advanced NSCLC

Outcome Measures

Primary Outcomes (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).

  Baseline up to 28 months

Secondary Outcomes (3)

• Progression Free Survival

  Baseline up to 28 months

• Number of Patients With Any Graded Adverse Event

  Baseline up to 28 months

• Overall Survival

  28 months

Study Arms (2)

Schedule A

EXPERIMENTAL

Subjects 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.

Drug: Cabazitaxel-XRP6258 (3-week cycle)

Schedule B

EXPERIMENTAL

Subjects 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.

Drug: Cabazitaxel-XRP6258 (5-week cycle)

Interventions

Cabazitaxel-XRP6258 (3-week cycle) DRUG

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.

Also known as: Jevtana

Schedule A

Cabazitaxel-XRP6258 (5-week cycle) DRUG

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.

Also known as: Jevtana

Schedule B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Sanofi: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Georgia Cancer Center

Atlanta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Francisco Robert, MD
• Organization: UAB

paco@uab.edu

205-934-5077

Study Officials

• Francisco Robert, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Locations

US (2)