check_circleStudy Completed

Carcinoma

Bayer Identifier:

100375

ClinicalTrials.gov Identifier:

NCT00941863

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

Trial purpose

The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Histologically confirmed solid tumors
    - Evaluable disease
    - Eastern Cooperative Oncology Group (ECOG) 0 or 1
    - Life expectancy minimum 12 weeks
  • - Congestive heart failure
    - Serious arrhythmias
    - Coronary artery disease (CAD) or ischemia
    - HIV (human immunodeficiency virus)
    - Hepatitis B or C
    - Serious active infection
    - Metastatic brain or meningeal tumors

Trial summary

Enrollment Goal
158
Trial Dates
July 2002 - April 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Vanderbilt University Medical SchoolNashville, 37232, United States
Completed
University of Wisconsin - MadisonMadison, 53792, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States

Primary Outcome

  • Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin
    MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Participants With Hematological and Biochemical Toxicities
    Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity >= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.
    date_rangeTime Frame:
    Start of treatment until death or within 14 days last study drug intake
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Tumor Response
    Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.
    date_rangeTime Frame:
    From start of treatment until progression or death occurs assessed every 6 weeks.
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1
    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.
    date_rangeTime Frame:
    At day 2 in study
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Concentration (CMAX) Start From Day 2 of Cycle 1
    Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.
    date_rangeTime Frame:
    At day 2 in study
    enhanced_encryption
    Safety Issue:
    No
  • Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1
    Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.
    date_rangeTime Frame:
    At day 2 in study
    enhanced_encryption
    Safety Issue:
    No

Trial design

Phase I Study to Determine the Safety, Maximum Tolerated Dose, PK of BAY43-9006 in Repeated Cycles of 18 Days On/3 Days Off in Combination With Paclitaxel and Carboplatin Chemotherapy in Patients With Advanced, Refractory Solid Tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
5

Additional Information

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