Phase 1
Completed N=46
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
Advanced Non-Hematologic Malignancies
Source: ClinicalTrials.gov NCT01653158 ↗
Enrolled (actual)
46
Serious AEs
63.0%
Results posted
Aug 2013
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — NA mg/kg
Summary
This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
NA | — |
| PRIMARY Recommended Phase 2 Dose (RP2D) |
20 | — |
| PRIMARY Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1 |
2852.11 | — |
| PRIMARY Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4 |
2526.19 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1 |
2770.71 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4 |
2438.34 | — |
| PRIMARY Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1 |
36.9428 | — |
| PRIMARY Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4 |
35.16 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1 |
2656.92 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4 |
2430 | — |
| PRIMARY Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1 |
35.4256 | — |
| PRIMARY Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4 |
35.3 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1 |
0.9179 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4 |
0.8066 | — |
| SECONDARY Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Objective Response (OR) |
— | — |
| SECONDARY Time to Tumor Progression (TTP) |
— | — |
| SECONDARY Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs) |
— | — |
| SECONDARY Systemic Clearance (CL) of CP-751,871 in Cycle 1 |
10.1; 7.00; 6.67; 9.23; 5.17; 3.53 | — |
| SECONDARY Systemic Clearance (CL) of CP-751,871 in Cycle 4 |
70.6; 12.90; 6.84; 3.05; 2.74; 2.68 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1 |
1.34; 7.81; 17.9; 33.4; 57.7; 129 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4 |
1.29; 6.91; 17.8; 54.7; 103; 188 | — |
| SECONDARY Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1 |
38.4; 1045; 2040; 5026; 10570; 26215 | — |
| SECONDARY Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1 |
949; 2744; 6532; 7799; 47711; 136026 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1 |
22.3; 673; 1685; 4568; 10712; 26215 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4 |
20.6; 521; 1728; 11802; 26329; 55466 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1 |
68.5; 97.4; 151; 150; 224; 174 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1 |
1.54; 8.76; 1.70; 9.41; 1.98; 3.21 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4 |
1.53; 1.65; 1.59; 2.25; 11.1; 3.23 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1 |
43.3; 40.1; 52.9; 83.2; 67.5; 37.5 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1 |
— | — |
| SECONDARY Volume of Distribution (Vz) of CP-751,871 in Cycle 1 |
41.7; 40.9; 55.1; 83.1; 67.9; 36.8 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Volume of Distribution (Vz) of CP-751,871 in Cycle 4 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1 |
— | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4 |
36.1; 745; 2978; 11802; 26329; 55466 | — |
| SECONDARY Observed Accumulation Ratio (Rac) of CP-751,871 |
0.852; 0.714; 1.48; 1.50; 2.16; 2.04 | — |
| SECONDARY Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4 |
0; 0; 0.185; 2.11; 9.07; 30.4 | — |
| SECONDARY Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years
- Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
- Eastern Cooperative Oncology Group [ECOG] performance status 0-1
Exclusion Criteria
- Significant active cardiac disease
- Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
- Inadequate bone marrow, renal, cardiac or liver function
Data sourced from ClinicalTrials.gov (NCT01653158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.