Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Inflammatory Agents

Hormones

Docetaxel

Prednisone

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

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.

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).

CP-751,871

Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.

docetaxel

Prednisone is administered at a dose of 5 mg twice daily.

prednisone

Pfizer CT.gov Call Center

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 of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

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

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.

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.

Levels of HAHA in serum were detected at baseline.

Levels of HAHA in serum were detected at the last follow-up visit.

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

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.

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.

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.

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.

Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.

Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.

CP-751,871+Docetaxel+Prednisone

Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.

Docetaxel+Prednisone

Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Docetaxel+Prednisone+CP-751,871 Crossover

Total

Less than (<) 18 years

18 to 44 years

45 to 64 years

Greater than or equal to (>=) 65 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.

Percentage of Participants With Prostate Specific Antigen (PSA) Best Response

Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.

Progression Free Survival (PFS)

All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.

Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)

All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.

Human Anti-human Antibody (HAHA) at the Last Follow-up Visit

Population PK Parameters of CP-751,871

Baseline (Cycle 1 Day 1) (n=46, 39)

Cycle 3 Day1 (n=28, 29)

Cycle 5 Day 1 (n=25, 23)

Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Total Number of Circulation Tumor Cells (CTCs)

Baseline (Cycle 1 Day 1) (n=22, 18)

Cycle 3 Day1 (n=12, 15)

Cycle 5 Day 1 (n=11, 10)

Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs

The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.

Quality of Life Measured by the Functional Assessment of Cancer Treatment-Prostate (FACT-P)

The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.

Pain Measured by the Modified Brief Pain Inventory-Short Form (mBPI-sf Modified Pfizer)

The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871

Maximum Observed Plasma Concentration (Cmax) for CP-751,871

Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871

Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.

Spots Global Cancer Trial Database for Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial