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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

City, postcode or hospital

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

Other trials in United States

About this study

Official title: An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma

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 groups in NCT01536145
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.

Dec 2003Jun 2008

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

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.

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

Results posted to the registry on 28 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP-751,871 0.025 mg/kg	3	0
CP-751,871 0.05 mg/kg	4	0
CP-751,871 0.1 mg/kg	3	1
CP-751,871 0.2 mg/kg	3	1
CP-751,871 0.4 mg/kg	4	2
CP-751,871 0.8 mg/kg	3	0
CP-751,871 1.5 mg/kg	3	1
CP-751,871 3 mg/kg	4	0
CP-751,871 6 mg/kg	3	0
CP-751,871 10 mg/kg	7	1
CP-751,871 20 mg/kg	10	0

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: Baseline up to Cycle 1 (Week 4 or Week 8). Number. Unit: mg/kg

Measure	CP-751,871 0.025-20 mg/kg n = 47
Value	NA

Population analysed: All participants who received at least 1 dose of study drug CP-751,871.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-751,871	21 of 47 (44.7%)	45 of 47 (95.7%)	Not reported

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.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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?

On the ClinicalTrials.gov record for NCT01536145.

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.