Study to Evaluate SID 530 Compared to Taxotere
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
1 other identifier
interventional
42
2 countries
4
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Oct 2009
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 24, 2013
August 1, 2010
1.3 years
June 30, 2009
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to test the bioequivalence of SID530 (test) to Taxotere
7 weeks
Secondary Outcomes (1)
to evaluate the of safety and tolerability of SID530 as compared to the marketed Taxotere.
7 weeks
Study Arms (2)
SID530
EXPERIMENTALStudy 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)
Taxotere
ACTIVE COMPARATORStudy 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Advanced Clinical Research Pharma
Miami, Florida, United States
Gabrail Cancer Center
Canton, Ohio, United States
City Cancer Hospital
Vijayawada AndhraPradesh, Ch. Venkatka Krishnayya, India
Kamakshi Memorial Hospital
No-1, Radial Road, Pallikarani, Chennai, Tamilnadu, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 24, 2013
Record last verified: 2010-08