Study to Evaluate SID 530 Compared to Taxotere

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00931008
First received: June 30, 2009
Last updated: January 22, 2013
Last verified: August 2010
  Purpose

This is a multi-center, randomized, blinded, two-period, two-sequence, crossover study, with a minimum 3-week washout period between treatments.The study is designed to evaluate the bioequivalence of SID530 to Taxotere.

It will be conducted in study participants with locally advanced or metastatic NSCLC who have failed platinum therapy and also in participants with locally advanced or metastatic breast cancer who have failed at least one line of chemotherapy.

Eligible study participants must be planning to have at least two consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy.

The duration of study participation will be approximately 7 weeks. The study has three study phases: Screening (<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: SID530, Taxotere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Two-Way Crossover, Bioequivalence Study of SID530 and Taxotere® in Study Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Platinum Therapy Failure or Study Participants With Locally Advanced or Metastatic Breast Cancer Who Have Failed At Least One Prior Chemotherapeutic Regimen

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • to test the bioequivalence of SID530 (test) to Taxotere [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate the of safety and tolerability of SID530 as compared to the marketed Taxotere. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SID530
Study participants who meet eligibility criteria will be randomized to one of two treatment sequences, SID530 or Taxotere (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1 followed by SID530 on Day 21)
Drug: SID530, Taxotere
75mg/m2
Active Comparator: Taxotere
Study participants who meet eligibility criteria will be randomized to one of two treatment sequences, SID530 or Taxotere (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1 followed by SID530 on Day 21)
Drug: SID530, Taxotere
75mg/m2

Detailed Description:

Study participants who meet eligibility criteria will be randomized to one of two treatment sequences (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1 followed by SID530 on Day 21). Randomization will be stratified by whether the study participant received prior docetaxel treatment.

All study participants will be premedicated with oral dexamethasone, 16 mg per day (e.g. 8 mg b.i.d.) for three days, starting one day prior to each study drug infusion, in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. During each treatment cycle, both the test and the reference treatments will receive identical dosages of docetaxel (i.e., 75 mg/m2, by i.v. infusion, over 1 hour).

Study completion will be defined as completing all protocol-specified procedures. Study participants who are prematurely withdrawn from the study will be requested to complete the assessments conducted at the Final Visit.

Blood samples for pharmacokinetic analysis will be obtained at the predefined times during Cycle 1 and Cycle 2.

Adverse events will be assessed throughout the study, including 21 days after the last study drug infusion. Hematology assessments,other laboratory parameters and vital signs will be assessed.

  Eligibility

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

Inclusion Criteria:Study participants

  • Has provided written informed consent
  • Is at least 18 years of age
  • Has histologically or cytologically confirmed non-small cell lung (NSCLC) or breast cancer (BC) that is locally advanced or metastatic
  • Has at least two planned consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy
  • Has a life expectancy of at least 3 months
  • Has Eastern Cooperative Oncology Group Performance Scale (ECOG PS) is in the range of 0-2 at the time of randomization
  • Has the Proper laboratory values within 1 week prior to randomization
  • Has negative serum pregnancy test within 1 week before first study drug administration (for women of childbearing potential, only)
  • Is willing to practice medically accepted contraception (if the risk of conception exists) throughout the study period (from Screening until the Final Visit)

Exclusion Criteria:Study participants

  • Has had any chemotherapy within 4 weeks before date of first study treatment
  • Has experienced severe side effects from (or severe hypersensitivity to) prior docetaxel treatment (or other drugs formulated with polysorbate 80, hydroxypropylbetadex, or povidone) such that discontinuation of the treatment was required
  • Has a history of hypersensitivity to dexamethasone
  • Is pregnant, lactating, or breastfeeding
  • Is taking one or more compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4
  • Has had treatment in another clinical study within the past 30 days
  • Has medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent
  • Is unlikely to comply with the protocol requirements, instructions and study-related restrictions
  • Has any other disease, dysfunction (including alcohol or drug abuse), physical examination or laboratory finding which, in the investigator's opinion, would exclude the participant from the study
  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: NCT00931008

Locations
United States, Florida
Advanced Clinical Research Pharma
Miami, Florida, United States
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States
India
City Cancer Hospital
Vijayawada AndhraPradesh, Ch. venkatka Krishnayya, India
Kamakshi Memorial Hospital
No-1, Radial Road, Pallikarani, Chennai, Tamilnadu, India
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
  More Information

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00931008     History of Changes
Other Study ID Numbers: SID530_2009
Study First Received: June 30, 2009
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014