Small Cell Lung CancerNCT01040312
An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors
An observational study of Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer
- What is being tested?
- CPT-11 and Platinum analogues
- How many people
- 321 participants
- Where
- 1 siteJapan
- Study dates
- 15 Oct 2009to 2 Sep 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in Japan with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice
Who may be able to join
- Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
- Has UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
- Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
Who cannot join
- Has contraindication for CPT-11
- Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Obstetrics and Gynecology, National Defense Medical College Hospital
Tokorozawa, 359-8513
About this study
Official title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.
- Conditions
- Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, Gastric Cancer (Inoperable and Recurrent)
- Being tested
- CPT-11, Platinum analogues
- Keywords
- UGT1A1, irinotecan
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPT-11Drug
Also called Camptosar, Topotecin
CPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.
Platinum analoguesDrug
Also called Cisplatin, Carboplatin, Nedaplatin
Platinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs.
| Study group | Role | What they receive |
|---|---|---|
| UGT1A1 genotyped patients | UGT1A1 genotyped patients receive CPT-11 with platinum analogues Receives: Drug: CPT-11; Drug: Platinum analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
Measured: within 6 months
Secondary outcomes (2)
Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues
Measured: within 6 months
Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study start15 Oct 2009
- Primary completion29 Sep 2014
- Study completion2 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040312
- Sponsor's protocol ID
- TOP009-062
- Other IDs
- 090946
- Status last verified
- May 2019
- First submitted
- 23 Dec 2009
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
- ClinicalTrials.gov ID
- NCT01040312
- Acronym / sponsor ID
- TOP009-062
- Conditions
- Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, Gastric Cancer (Inoperable and Recurrent)
- Keywords
- UGT1A1, irinotecan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2009 (actual)
- Primary completion
- 29 Sep 2014 (actual)
- Study completion
- 2 Sep 2015 (actual)
- First posted
- 29 Dec 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.
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UGT1A1 genotyped patients | – | Drug: CPT-11, Drug: Platinum analoguesUGT1A1 genotyped patients receive CPT-11 with platinum analogues |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in Japan with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice
Key inclusion criteria (3 listed)
- Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
- Has UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
- Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
Key exclusion criteria (2 listed)
- Has contraindication for CPT-11
- Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
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 |
|---|---|---|
| CPT-11Also: Camptosar, TopotecinCPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog. | Drug | UGT1A1 genotyped patients |
| Platinum analoguesAlso: Cisplatin, Carboplatin, NedaplatinPlatinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs. | Drug | UGT1A1 genotyped patients |
Primary outcome
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
Time frame: within 6 months
2 secondary outcomes
Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues
Time frame: within 6 months
Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype
Time frame: within 6 months
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 23 May 2019.
- Individual participant dataSharing planned: No
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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.
Clinical Study Leader study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
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 3 inclusion and 2 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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?
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues (time frame: within 6 months). 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 23 May 2019.