Status:
TERMINATED
Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
Lead Sponsor:
Sanofi
Conditions:
Neoplasms, Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 gemcitab...
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 d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01001221
Start Date
November 1 2009
End Date
October 1 2011
Last Update
September 11 2013
Active Locations (4)
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1
Investigational Site Number 840002
Detroit, Michigan, United States, 48201
2
Investigational Site Number 840005
Cincinnati, Ohio, United States, 45267-0542
3
Investigational Site Number 840004
Philadelphia, Pennsylvania, United States, 19111
4
Investigational Site Number 840001
Nashville, Tennessee, United States, 37232