Ovarian CancerPhase 1/2NCT00831636
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
A Phase 1/2 study testing CP-4055 in people with Ovarian Cancer, run by Clavis Pharma at 5 sites in 2 countries.
Trial summary
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design 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?
- CP-4055
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2008to Apr 2010
- Phase
- Phase 1/2
- 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
- Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
- Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
- Evidence of platinum resistant or refractory disease
- ECOG Performance Status 0 - 1
- Life expectancy > 3 months
- Signed informed consent (IC)
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- Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
- Women of child-bearing potential must not become pregnant while participating in the study
- Adequate haematological and biological functions
Who cannot join
- Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
- Known brain metastases
- Another known active cancer within the last 5 years
- Radiotherapy to more than 30 % of bone marrow
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Concomitant treatment with a non-permitted medication
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- A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
- Any serious concomitant systemic disorders incompatible with the clinical study
- Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnancy or breastfeeding
- Known positive status for HIV and/or hepatitis B or C
- Drug and/or alcohol abuse
- Any reason why, in the investigator's opinion, the patient should not participate
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Italy4 sites
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
Aviano (PN)
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
Naples, IT-80131
Department of Oncology, Catholic University of the Sacred Heart
Rome, 00168
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Rome
Belgium1 site
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, B-3000
About this study
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
Read the detailed description
Phase I
- Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
- Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established
Phase II
- Step 1 (The patient inclusion may stop after this step):
- Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL
- Step 2:
- Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2
- Conditions
- Ovarian Cancer
- Being tested
- CP-4055
- Keywords
- CP-4055, Cancer, Metastatic, Solid tumors, advanced ovarian cancer, stage III and IV ovarian cancer, advanced epithelian ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-4055Drug
D1-5 and D8(+2)-12(+2) q4w
CP-4055Drug
IV administration day 1-5 and day 8-12 in a 4 week schedule
| Study group | Role | What they receive |
|---|---|---|
| Open label CP-4055 | Experimental | Phase I: Dose escalation Phase II: Fixed dose Receives: Drug: CP-4055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
Measured: August 2009/June 2010
Phase II: Determine the antitumour activity of CP-4055
Measured: August 2009/June 2010
Secondary outcomes (4)
Determine pharmacokinetic (PK) parameters
Measured: August 2009/June 2010
Explore the time to progression (TTP)
Measured: August 2009/June 2010
Investigate the duration of tumour response
Measured: August 2009/June 2010
Determine the nature and degree of toxicity of CP-4055 in this patient population
Measured: August 2009/June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionApr 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clavis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandro Pignata, MD, Principal investigator, Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831636
- Sponsor's protocol ID
- CP4055-204
- Status last verified
- Sep 2013
- First submitted
- 28 Jan 2009
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00831636
- Acronym / sponsor ID
- CP4055-204
- Conditions
- Ovarian Cancer
- Keywords
- CP-4055, Cancer, Metastatic, Solid tumors, advanced ovarian cancer, stage III and IV ovarian cancer, advanced epithelian ovarian cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Clavis PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Jan 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 non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
Detailed description
Phase I
- Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
- Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established
Phase II
- Step 1 (The patient inclusion may stop after this step):
- Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL
- Step 2:
- Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label CP-4055 | Experimental | Drug: CP-4055Phase I: Dose escalation Phase II: Fixed dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
- Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
- Evidence of platinum resistant or refractory disease
- ECOG Performance Status 0 - 1
- Life expectancy > 3 months
Key exclusion criteria (13 listed)
- Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
- Known brain metastases
- Another known active cancer within the last 5 years
- Radiotherapy to more than 30 % of bone marrow
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
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 |
|---|---|---|
| CP-4055D1-5 and D8(+2)-12(+2) q4w | Drug | Open label CP-4055 |
| CP-4055IV administration day 1-5 and day 8-12 in a 4 week schedule | Drug | Open label CP-4055 |
Primary outcome
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
Time frame: August 2009/June 2010
Phase II: Determine the antitumour activity of CP-4055
Time frame: August 2009/June 2010
4 secondary outcomes
Determine pharmacokinetic (PK) parameters
Time frame: August 2009/June 2010
Explore the time to progression (TTP)
Time frame: August 2009/June 2010
Investigate the duration of tumour response
Time frame: August 2009/June 2010
Determine the nature and degree of toxicity of CP-4055 in this patient population
Time frame: August 2009/June 2010
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 13 Sep 2013.
- Clavis Pharma Home PageLink provided by the sponsor.
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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.
Sandro Pignata, MD principal investigator
Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CP-4055 in people with Ovarian Cancer, run by Clavis Pharma at 5 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 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w (time frame: August 2009/June 2010). The study lists 2 primary outcomes in all. 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 13 Sep 2013.