Multiple MyelomaPhase 1NCT01536145
CP-751,871 Treatment For Patients With Multiple Myeloma
A Phase 1 study testing CP-751,871 in people with Multiple Myeloma, run by Pfizer at 6 sites in United States.
Trial summary
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CP-751,871
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2003to Jun 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
- Adequate bone marrow, renal, liver and cardiac function
- Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2
Who cannot join
- Prior allogeneic stem cell transplant (alloSCT)
- Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
- Prior organ allograft
- Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
- Female patients who are pregnant or lactating
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
New York, New York, 10011-5903
Pfizer Investigational Site
Phoenix, Arizona, 85054
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Scottsdale, Arizona, 85259
Pfizer Investigational Site
Tampa, Florida, 33612
About this study
Official title: An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.
- Conditions
- Multiple Myeloma
- Being tested
- CP-751,871
- Keywords
- IGF-1R inhibitor, CP-751871, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability
| Study group | Role | What they receive |
|---|---|---|
| Single agent CP-751,871 | Experimental | dose escalation design Receives: Drug: CP-751,871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
Measured: Baseline up to Cycle 1 (Week 4 or Week 8)
Secondary outcomes (13)
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871
Measured: 1 hour postdose in Cycle 1
Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Volume of Distribution (Vz) for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Plasma Decay Half-life (t1/2) for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Systemic Clearance (CL) for CP-751,871
Measured: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Multiple Dose Cinf for CP-751,871
Measured: 1 hour postdose in Cycles 2 up to 16
Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Measured: 0 hour (predose) in Cycles 2 up to 16
Pharmacodynamic-based Dose
The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression
Measured: Cycle 1 (Week 4 or Week 8)
Human Anti-human Antibody (HAHA) Response to CP-751,871
Measured: 30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).
Measured: Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
Time to Disease Progression
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])
Measured: Baseline up to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startDec 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536145
- Sponsor's protocol ID
- A4021001
- Status last verified
- Mar 2013
- First submitted
- 14 Feb 2012
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01536145
- Acronym / sponsor ID
- A4021001
- Conditions
- Multiple Myeloma
- Keywords
- IGF-1R inhibitor, CP-751871, multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 28 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single agent CP-751,871 | Experimental | Drug: CP-751,871dose escalation design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
- Adequate bone marrow, renal, liver and cardiac function
- Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2
Key exclusion criteria (5 listed)
- Prior allogeneic stem cell transplant (alloSCT)
- Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
- Prior organ allograft
- Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
- Female patients who are pregnant or lactating
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-751,871CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability | Drug | Single agent CP-751,871 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Baseline up to Cycle 1 (Week 4 or Week 8)
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
13 secondary outcomes
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871
Time frame: 1 hour postdose in Cycle 1
Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Volume of Distribution (Vz) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Plasma Decay Half-life (t1/2) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Single Dose Systemic Clearance (CL) for CP-751,871
Time frame: Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose
Multiple Dose Cinf for CP-751,871
Time frame: 1 hour postdose in Cycles 2 up to 16
Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Time frame: 0 hour (predose) in Cycles 2 up to 16
Pharmacodynamic-based Dose
Time frame: Cycle 1 (Week 4 or Week 8)
Human Anti-human Antibody (HAHA) Response to CP-751,871
Time frame: 30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg
Percentage of Participants With Objective Response (OR)
Time frame: Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)
Time to Disease Progression
Time frame: Baseline up to end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-751,871 in people with Multiple Myeloma, run by Pfizer at 6 sites in United States.
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 5 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) (time frame: Baseline up to Cycle 1 (Week 4 or Week 8)). 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 15 Mar 2013.