Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

This study has been terminated.
(Maximum tolerated dose not able to be determined)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01001221
First received: October 23, 2009
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

Primary Objectives:

  • Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies.
  • Study part 2: To determine the antitumor activity of cabazitaxel in combination with gemcitabine, in an additional extended cohort of 15 patients with advanced solid malignancies treated with the defined MTD, as assessed by objective response rate (ORR) according to the revised guideline for Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria).

Secondary Objectives:

  • To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine.
  • To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2' difluorodeoxyuridine (dFdU) when given in combination.
  • To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the study and the patients who received the MTD in Part 1 component.

For study part 1, dose levels were to be escalated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further dose escalation when this dose was achieved. The MTD was defined as the highest dose at which 0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of treatment.


Condition Intervention Phase
Neoplasms, Malignant
Drug: cabazitaxel
Drug: gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Participants With Dose Limiting Toxicities During Dose Escalation [ Time Frame: Day 1 to Day 21 of the first treatment cycle ] [ Designated as safety issue: Yes ]
    Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).

  • Objective Response Rate With MTD [ Time Frame: Fron Day 1 up to a maximum of 12 months ] [ Designated as safety issue: No ]

    Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.

    CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm.

    PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.

    The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed.



Secondary Outcome Measures:
  • Time To Progression With MTD [ Time Frame: Fron Day 1 up to a maximum of 12 months ] [ Designated as safety issue: No ]

    Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions).

    Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed.


  • Duration of Response With MTD [ Time Frame: Fron Day 1 up to a maximum of 12 months ] [ Designated as safety issue: No ]

    Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.

    Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed.


  • Participants With Adverse Events [ Time Frame: from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks) ] [ Designated as safety issue: Yes ]

    Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.

    Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.

    NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling.


  • Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]

    Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.

    Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis.


  • Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.

  • Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
    Area under the plasma concentration versus time curve extrapolated to infinity

  • Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA) [ Time Frame: before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]

    Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:

    • Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;
    • Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;

    Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

    PK parameters were calculated from plasma concentrations using non-compartmental analysis.


  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]

    Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:

    • Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;
    • Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;

    Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

    PK parameters were calculated from plasma concentrations using non-compartmental analysis.


  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]

    Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).

    2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

    PK parameters were calculated from plasma concentrations using non-compartmental analysis.


  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC) [ Time Frame: 7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]

    Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).

    2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.

    PK parameters were calculated from plasma concentrations using non-compartmental analysis.


  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC) [ Time Frame: 7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC [ Time Frame: Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) ] [ Designated as safety issue: No ]
    Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.


Enrollment: 19
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel + gemcitabine

Cabazitaxel and gemcitabine on Day 1 then gemcitabine alone on Day 8 every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.

On Day 1, cabazitaxel was given either first followed by gemcitabine (part 1a) or after gemcitabine with 1 hour gap between the two infusions (part 1b). Required premedication with antihistamine, corticosteroid and H2 antagonist was administered intravenously 30 minutes before each dose of cabazitaxel.

Drug: cabazitaxel

Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion

Route of administration: Intravenous infusion over 60 minutes

Dosage:

  • Study part 1: 15, 20 or 25 mg/m^2 according to pre-defined dose escalation schedule
  • Study part 2: MTD as determined in Study part 1
Other Names:
  • XRP6258
  • Jevtana
Drug: gemcitabine

Pharmaceutical form: According to United States Package Insert (USPI)

Route of administration: Intravenous infusion over 30 minutes

Dosage:

  • Study part 1: 700, 900 or 1000 mg/m^2 according to pre-defined dose escalation schedule
  • Study part 2: MTD as determined in Study part 1.
Other Name: Gemzar

Detailed Description:

The study consisted of a screening phase (maximum length of 21-day), a treatment phase with 21-day treatment cycles and a 30-day follow-up visit after the last dose of study medication.

The cut-off date for study part 1 was when last participant completed the first treatment cycle and the subsequent 30 days follow-up.

The cut off date for study part 2 was when all participants experienced disease progression, unacceptable toxicity, consent withdrawal or the last participant had completed 26 weeks or 6 cycles on study treatment, whichever came first.

Participants could continue to be treated on study as long as they were benefiting from study treatment and had not met study withdrawal criteria. After withdrawal from study treatment, further treatment, if any, was at the discretion of the Investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) > or =2
  • Anticipation of need for a major surgical procedure or radiation therapy during the study treatment
  • Absence of completion of all prior chemotherapy, biological therapy, targeted non-cytotoxic therapy > or = 3 weeks; and radiotherapy > or = 4 weeks prior to registration. For part 2 only, prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies are not directed to the areas of measurable disease being used for the purposes of this protocol. (4 weeks of washout period is required prior to start the treatment in Part 2)
  • Concurrent treatment in another clinical trial or with any other cancer therapy or patients planning to receive these treatments during the study
  • Other concurrent serious illness or medical condition, including active infection or human immunodeficiency virus (HIV) disease
  • History of any other malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
  • Patients without resolution of all clinically significant toxic effects (excluding alopecia) of any prior therapy to grade < or = 1 by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0 or to within the limits listed in the specific inclusion/exclusion criteria
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
  • Symptomatic brain metastases or leptomeningeal disease. Patients with asymptomatic or stable brain metastases are allowed
  • Women of childbearing potential not protected by highly effective contraceptive method of birth control. All patients of childbearing potential that do not have a negative pregnancy test within the 7 days prior to registration
  • Patients who are pregnant or breastfeeding
  • For part 2, absence of measurable disease as defined by the most current version of the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. For the Part 1 component, patients with non-measurable disease are accepted
  • Inadequate bone marrow or liver or renal organ function
  • Any condition which is considered a contraindication to gemcitabine in the local labelling
  • Prior treatment with cabazitaxel within the last 2 years
  • History of severe hypersensitivity grade 3 or 4 to taxanes, Polysorbate-80, or to compounds with similar chemical structures

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001221

Locations
United States, Michigan
Investigational Site Number 840002
Detroit, Michigan, United States, 48201
United States, Ohio
Investigational Site Number 840005
Cincinnati, Ohio, United States, 45267-0542
United States, Pennsylvania
Investigational Site Number 840004
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Investigational Site Number 840001
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01001221     History of Changes
Other Study ID Numbers: TCD11068
Study First Received: October 23, 2009
Results First Received: May 20, 2013
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 14, 2014