Ovarian CancerPhase 2NCT00291837
CT-2106 for the Second Line Treatment of Ovarian Cancer
A Phase 2 study testing CT-2106 in people with Ovarian Cancer, run by CTI BioPharma at 7 sites in 3 countries.
Trial summary
The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- CT-2106
- How many people
- 40 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Nov 2004to Dec 2007
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
- Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
- At least one measurable lesion according to RECIST
- ECOG performance status 0 or 1
- at least 18 years old
- Adequate haematological function
- Adequate renal and hepatic functions
- Normal coagulation parameters
Who cannot join
- Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis;
- Current active infection per investigator assessment;
- Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
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- Current history of chronic diarrhea >= grade 1 (CTCAE version 3);
- Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
- Other uncontrolled, serious illness or medical condition, as determined by the investigator;
- Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
- Concurrent treatment with any other anti-cancer therapy;
- Known HIV positivity or AIDS-related illness;
- Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United Kingdom4 sites
Study site
Birmingham
Study site
London
Study site
Newcastle upon Tyne
Study site
Surrey
About this study
Official title: Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen
The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.
- Conditions
- Ovarian Cancer
- Being tested
- CT-2106
- Keywords
- ovarian, CT-2106
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-2106Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Secondary outcomes (4)
toxicity
response duration
time to progression
survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startNov 2004
- Primary completionJun 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hilary Calvert, PhD, Principal investigator, Newcastle General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291837
- Sponsor's protocol ID
- CAM203
- Status last verified
- Feb 2010
- First submitted
- 14 Feb 2006
- Last updated
- 26 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen
- ClinicalTrials.gov ID
- NCT00291837
- Acronym / sponsor ID
- CAM203
- Conditions
- Ovarian Cancer
- Keywords
- ovarian, CT-2106
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Feb 2006 (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 sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
- Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
- At least one measurable lesion according to RECIST
- ECOG performance status 0 or 1
- at least 18 years old
Key exclusion criteria (13 listed)
- Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis;
- Current active infection per investigator assessment;
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 |
|---|---|---|
| CT-2106 | Drug | – |
Primary outcome
response rate
4 secondary outcomes
toxicity
response duration
time to progression
survival
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 26 Feb 2010.
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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.
Hilary Calvert, PhD principal investigator
Newcastle General Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-2106 in people with Ovarian Cancer, run by CTI BioPharma at 7 sites in 3 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 8 inclusion and 13 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 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, France, Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
response rate. 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 26 Feb 2010.