Non-Small Cell Lung CancerPhase 3NCT00931008
Study to Evaluate SID 530 Compared to Taxotere
A Phase 3 study testing SID530, Taxotere in people with Non-Small Cell Lung Cancer, run by SK Chemicals Co., Ltd. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- SID530, Taxotere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2009to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Gabrail Cancer Center
Canton, Ohio
Advanced Clinical Research Pharma
Miami, Florida
India2 sites
Kamakshi Memorial Hospital
No-1, Radial Road, Pallikarani, Chennai, Tamilnadu
City Cancer Hospital
Vijayawada AndhraPradesh, Ch. Venkatka Krishnayya
About this study
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
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.
Read more
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).
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SID530, Taxotere
- Keywords
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SID530, TaxotereDrug
75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| SID530 | Experimental | 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) Receives: Drug: SID530, Taxotere |
| Taxotere | Active comparator | 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) Receives: Drug: SID530, Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
to test the bioequivalence of SID530 (test) to Taxotere
Measured: 7 weeks
Secondary outcomes (1)
to evaluate the of safety and tolerability of SID530 as compared to the marketed Taxotere.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931008
- Sponsor's protocol ID
- SID530_2009
- Status last verified
- Aug 2010
- First submitted
- 30 Jun 2009
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00931008
- Acronym / sponsor ID
- SID530_2009
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SID530 | Experimental | Drug: SID530, TaxotereStudy 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 comparator | Drug: SID530, TaxotereStudy 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SID530, Taxotere75mg/m2 | Drug | SID530, Taxotere |
Primary outcome
to test the bioequivalence of SID530 (test) to Taxotere
Time frame: 7 weeks
1 secondary outcome
to evaluate the of safety and tolerability of SID530 as compared to the marketed Taxotere.
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SID530, Taxotere in people with Non-Small Cell Lung Cancer, run by SK Chemicals Co., Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to test the bioequivalence of SID530 (test) to Taxotere (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.