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A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies

Phase 1/Phase 2
18 Years
Not Enrolling
Neoplasms, Malignant

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Trial Information

A Dose-Escalation, Single Arm, Combination Study of Cabazitaxel With Gemcitabine to Determine The Safety, And Pharmacokinetics In Subjects With Advanced Solid Malignancies

The study consists of a screening phase (maximum length of 21-day), a treatment phase with
21-day study treatment cycles. Cycle lengths may be extended up to maximum of 2 additional
weeks in case of unresolved toxicity. Patients will be treated until disease progression or
unacceptable toxicities, withdrawal of consent or Investigator's decision.There will be a
30-day follow-up visit after the last dose of study medication. Patients who discontinue
study treatment prior to disease progression will continue to have tumor assessments every 6
weeks until disease progression or start of an other anticancer therapy.

The cut off date for the study is defined as follows: all patients will be followed up until
disease progression, unacceptable toxicity, consent withdrawal or when the last patient had
completed 26 weeks or 6 cycles on study treatment, whichever comes first. Patients may
continue to be treated on study as long as they are benefiting from study treatment and have
not met study withdrawal criteria. After withdrawal from study treatment, further treatment,
if any, is at the discretion of the Investigator.

Inclusion 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:

- 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
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 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 RECIST 1.1. For the Part 1 component, patients with non-measurable disease are

- Inadequate bone marrow or liver or renal organ function

- Any condition which is considered a contraindication to gemcitabine in the local

- 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

- Any treatment known to potentially interact with midazolam

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1: DLTs of the combination of cabazitaxel and gemcitabine

Outcome Time Frame:

3 weeks (cycle 1)

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

October 2011

Related Keywords:

  • Neoplasms, Malignant
  • Neoplasms



Investigational Site Number 840002Detroit, Michigan  48201
Investigational Site Number 840005Cincinnati, Ohio  45267-0542
Investigational Site Number 840004Philadelphia, Pennsylvania  19111
Investigational Site Number 840001Nashville, Tennessee  37232