NeoplasmsPhase 1NCT01146171
Japanese Phase 1 Study of BMS-844203 (CT322)
A Phase 1 study testing BMS-844203 (CT-322) in people with Neoplasms, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BMS-844203 (CT-322)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Jan 2015
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
Who cannot join
- Subject has uncontrolled diabetes or hypertension
- Clinical significant bleeding diathesis or coagulopathy
- Thrombotic or embolic cerebrovascular accident
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
- Conditions
- Neoplasms
- Being tested
- BMS-844203 (CT-322)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-844203 (CT-322)Drug
Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent
| Study group | Role | What they receive |
|---|---|---|
| BMS-844203 (CT-322) | Experimental | Not described Receives: Drug: BMS-844203 (CT-322) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recommended dose for Phase 2 study of CT-322
Measured: Within the first 28 days
Secondary outcomes (7)
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Measured: Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Measured: Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
To assess anti-tumor activity of CT-322
Measured: Every 8 weeks
To assess the effects of CT-322 on plasma VEGF levels
Measured: Cycle 1: Day 1, 3, 8, 15, 22
To assess the effects of CT-322 on plasma VEGF levels
Measured: Cycle 3: Day 1
To assess the presence of anti CT-322 antibodies
Measured: Cycle 1: Day 1, 15, 22 and 29
To assess the presence of anti CT-322 antibodies
Measured: Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startNov 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146171
- Sponsor's protocol ID
- CA196-007
- Status last verified
- Feb 2012
- First submitted
- 10 Jun 2010
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01146171
- Acronym / sponsor ID
- CA196-007
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 17 Jun 2010 (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 clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-844203 (CT-322) | Experimental | Drug: BMS-844203 (CT-322) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
Key exclusion criteria (3 listed)
- Subject has uncontrolled diabetes or hypertension
- Clinical significant bleeding diathesis or coagulopathy
- Thrombotic or embolic cerebrovascular accident
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 |
|---|---|---|
| BMS-844203 (CT-322)Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent | Drug | BMS-844203 (CT-322) |
Primary outcome
Determine recommended dose for Phase 2 study of CT-322
Time frame: Within the first 28 days
7 secondary outcomes
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Time frame: Cycle 1: Day 1 to 5, 8, 15, 22 to 26 and 29
To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc.
Time frame: Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
To assess anti-tumor activity of CT-322
Time frame: Every 8 weeks
To assess the effects of CT-322 on plasma VEGF levels
Time frame: Cycle 1: Day 1, 3, 8, 15, 22
To assess the effects of CT-322 on plasma VEGF levels
Time frame: Cycle 3: Day 1
To assess the presence of anti CT-322 antibodies
Time frame: Cycle 1: Day 1, 15, 22 and 29
To assess the presence of anti CT-322 antibodies
Time frame: Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-844203 (CT-322) in people with Neoplasms, run by Bristol-Myers Squibb 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 3 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: withdrawn, as of the sponsor's last update on 7 Feb 2012. 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.
What does this 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determine recommended dose for Phase 2 study of CT-322 (time frame: Within the first 28 days). 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 7 Feb 2012.