Prostatic NeoplasmsPhase 2NCT00313781
Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
A Phase 2 study testing CP-751,871, docetaxel and prednisone in people with Prostatic Neoplasms, run by Pfizer at 18 sites in 6 countries.
Trial summary
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- CP-751,871, docetaxel and prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 18 sitesin 6 countries
- Study dates
- May 2006to Dec 2011
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metastatic, progressive hormone refractory prostate cancer
- Adequate bone marrow, liver and kidney function
Who cannot join
- Previous treatment with chemotherapy
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
United States6 sites
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cleveland, Ohio, 44195-0001
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Orange, Ohio, 44122
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111-2497
United Kingdom4 sites
Pfizer Investigational Site
Glasgow, G12 0YH
Pfizer Investigational Site
Glasgow, G52 3NQ
Pfizer Investigational Site
Guildford, GU2 7WG
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
Spain3 sites
Pfizer Investigational Site
A Coruña, A Coruña, 15006
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Canada2 sites
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Germany2 sites
Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
München, 81675
About this study
Official title: A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate Cancer
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy
- Conditions
- Prostatic Neoplasms
- Being tested
- CP-751,871, docetaxel, prednisone
- Keywords
- randomized, non-comparative, efficacy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).
docetaxelDrug
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisoneDrug
Prednisone is administered at a dose of 5 mg twice daily.
docetaxelDrug
Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.
prednisoneDrug
Prednisone is administered at a dose of 5 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. Receives: Drug: CP-751,871; Drug: docetaxel; Drug: prednisone |
| B | Active comparator | Not described Receives: Drug: docetaxel; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.
Measured: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)
Secondary outcomes (12)
Progression Free Survival (PFS)
PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.
Measured: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)
Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)
Levels of HAHA in serum were detected at baseline.
Measured: Baseline (Day 1 of Cycle 1)
Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
Levels of HAHA in serum were detected at the last follow-up visit.
Measured: The last follow-up visit (150 days post last dose)
Population PK Parameters of CP-751,871
Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations
Measured: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Total Number of Circulation Tumor Cells (CTCs)
Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.
Measured: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.
Measured: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)
The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.
Measured: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)
The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an "X" in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block.
Measured: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871
Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.
Measured: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Maximum Observed Plasma Concentration (Cmax) for CP-751,871
Measured: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Measured: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871
Measured: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2011
- Study completionDec 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 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
- NCT00313781
- Sponsor's protocol ID
- A4021011
- Status last verified
- Mar 2013
- First submitted
- 10 Apr 2006
- Last updated
- 11 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
de Bono JS, Piulats JM, Pandha HS, Petrylak DP, Saad F, Aparicio LM, Sandhu SK, Fong P, Gillessen S, Hudes GR, Wang T, Scranton J, Pollak MN. Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2014 Apr 1;20(7):1925-34. doi: 10.1158/1078-0432.CCR-13-1869. Epub 2014 Feb 17.
PubMed 24536060
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00313781
- Acronym / sponsor ID
- A4021011
- Conditions
- Prostatic Neoplasms
- Keywords
- randomized, non-comparative, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Posted 11 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CP-751,871, Drug: docetaxel, Drug: prednisoneFor patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. |
| B | Active comparator | Drug: docetaxel, Drug: prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of metastatic, progressive hormone refractory prostate cancer
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (1 listed)
- Previous treatment with chemotherapy
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-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days). | Drug | A |
| docetaxelDocetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. | Drug | A |
| prednisonePrednisone is administered at a dose of 5 mg twice daily. | Drug | A |
| docetaxelDocetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. | Drug | B |
| prednisonePrednisone is administered at a dose of 5 mg twice daily. | Drug | B |
Primary outcome
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
Time frame: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)
Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.
12 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)
Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)
Time frame: Baseline (Day 1 of Cycle 1)
Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
Time frame: The last follow-up visit (150 days post last dose)
Population PK Parameters of CP-751,871
Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Total Number of Circulation Tumor Cells (CTCs)
Time frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
Time frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)
Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)
Time frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)
Time frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871
Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Maximum Observed Plasma Concentration (Cmax) for CP-751,871
Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871
Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871
Time frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24536060de Bono JS, Piulats JM, Pandha HS, Petrylak DP, Saad F, Aparicio LM, Sandhu SK, Fong P, Gillessen S, Hudes GR, Wang T, Scranton J, Pollak MN. Phase II randomized study of figitumumab plus docetaxel and docetaxel alone with crossover for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2014 Apr 1;20(7):1925-34. doi: 10.1158/1078-0432.CCR-13-1869. Epub 2014 Feb 17.
- 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
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-751,871, docetaxel and prednisone in people with Prostatic Neoplasms, run by Pfizer at 18 sites in 6 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 2 inclusion and 1 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 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom, Spain, Canada, Germany and 1 more country. 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?
Yes. Results are posted in the registry (first posted 11 Apr 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?
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response (time frame: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)). 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 NCT00313781, which also lists 1 linked publication.
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 11 Apr 2013.