Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Sarcoma
Conditions
Keywords
advanced solid tumors cancer refractory cancer figitumumab pegvisomant
Brief summary
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
Detailed description
This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.
Interventions
DRUGfigitumumab
IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
DRUGpegvisomant
growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options. * Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort. * Adequate recovery from prior therapies. * Adequate organ function (i.e. bone marrow, kidney, liver) * Total IGF-1 ≥100 ng/ml (13 nmol/L).
Exclusion criteria
* Concurrent treatment with any anti-tumor agents. * Pregnant or breastfeeding females. * Significant past history or active cardiac disease * Active infection * History of diabetes mellitus. * Glycosylated hemoglobin \>5.7
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Screening to the follow-up visit (90 days after last dose of figitimumab) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade \[Gr\] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Number of Participants With Dose Limiting Toxicities (DLT) | From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2 | DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting \>=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever \>=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr \>=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia \>=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Figitumumab | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit | — |
| Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 | — |
| Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit | Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment. |
| Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab | Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1. |
| Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) | The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed. |
| Area Under the Trough Concentrations (AUCtrough) | Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit | The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods. |
| Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Screening; Day 8 of Cycle 1; Day 15 of Cycle 2 | The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant. |
| Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab | Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) | Percentage of participants with positive total or neutralizing ADA for figitumumab. |
| Number of Participants With Objective Response | From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab) | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1 |
| Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 | — |
Countries
Canada, Finland, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Figitumumab 20 mg/kg +Pegvisomant 10 mg Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. | 17 |
| Figitumumab 20 mg/kg + Pegvisomant 20 mg Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 1 |
| Overall Study | Disease Progression | 4 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Subject Enrolled in Hospice | 1 | 0 |
| Overall Study | Terminated by the Sponsor | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Figitumumab 20 mg/kg +Pegvisomant 10 mg | Figitumumab 20 mg/kg + Pegvisomant 20 mg | Total |
|---|---|---|---|
| Age Continuous | 49.5 Years STANDARD_DEVIATION 17.4 | 32.3 Years STANDARD_DEVIATION 9.8 | 45.0 Years STANDARD_DEVIATION 17.4 |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 1 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 17 | 6 / 6 |
| serious Total, serious adverse events | 9 / 17 | 4 / 6 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade \[Gr\] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: From Screening to the follow-up visit (90 days after last dose of figitimumab)
Population: Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs | 17 Participants |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with SAEs | 9 Participants |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with Gr 3 or Gr 4 AEs | 12 Participants |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with Gr 5 AEs | 7 Participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with Gr 5 AEs | 1 Participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs | 6 Participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with Gr 3 or Gr 4 AEs | 4 Participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with SAEs | 4 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLT)
DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting \>=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever \>=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr \>=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia \>=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.
Time frame: From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2
Population: Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Dose Limiting Toxicities (DLT) | 1 participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Dose Limiting Toxicities (DLT) | 0 participants |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1
Time frame: Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Area Under the Trough Concentrations (AUCtrough)
The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.
Time frame: Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.
Time frame: Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Time frame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
Time frame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Time frame: Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Mean Change in Glucose Levels Between Fasting and Post Glucose Load
The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.
Time frame: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
Population: Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Screening (n = 17, 6) | 30.35 milligram/deciliter (mg/dL) | Standard Deviation 34.02 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Cycle 1 Day 8 (n = 15, 5) | 37.68 milligram/deciliter (mg/dL) | Standard Deviation 30.95 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Cycle 2 Day 15 (n = 4, 5) | 55.15 milligram/deciliter (mg/dL) | Standard Deviation 49.35 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Screening (n = 17, 6) | 4.67 milligram/deciliter (mg/dL) | Standard Deviation 17.6 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Cycle 1 Day 8 (n = 15, 5) | 15.40 milligram/deciliter (mg/dL) | Standard Deviation 32.04 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | Cycle 2 Day 15 (n = 4, 5) | 13.40 milligram/deciliter (mg/dL) | Standard Deviation 28.35 |
Secondary
Number of Participants With Objective Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Time frame: From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)
Population: Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Number of Participants With Objective Response | 0 participants |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Number of Participants With Objective Response | 3 participants |
Secondary
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Percentage of participants with positive total or neutralizing ADA for figitumumab.
Time frame: Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Population: ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.
Time frame: Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Population: PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
Secondary
Serum Circulating Insulin-like Growth Factor (IGF-1) Levels
The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.
Time frame: Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Population: Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 15 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 4 (n = 5, 3) | 542.09 nanogram/milliliter (ng/mL) | Standard Deviation 510.84 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 16 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 8 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 17 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Baseline/Cycle 1 (n = 16, 6) | 150.18 nanogram/milliliter (ng/mL) | Standard Deviation 77.06 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 18 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 9 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 19 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 5 (n = 3, 4) | 990.40 nanogram/milliliter (ng/mL) | Standard Deviation 542.21 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 20 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 10 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 21 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 11 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 22 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 3 (n = 6, 5) | 474.53 nanogram/milliliter (ng/mL) | Standard Deviation 418.39 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 23 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 12 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 24 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 6 (n = 2, 2) | 1369.5 nanogram/milliliter (ng/mL) | Standard Deviation 161.93 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 25 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 13 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 26 (n = 0, 1) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 2 (n = 12, 6) | 725.72 nanogram/milliliter (ng/mL) | Standard Deviation 497.12 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 27 (n = 0, 0) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 14 (n = 0, 2) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Follow-Up (n = 2, 1) | 791.50 nanogram/milliliter (ng/mL) | Standard Deviation 813.88 |
| Figitumumab 20mg/kg + Pegvisomant 10 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 7 (n = 1, 2) | 1594.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Follow-Up (n = 2, 1) | 1285.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Baseline/Cycle 1 (n = 16, 6) | 189.17 nanogram/milliliter (ng/mL) | Standard Deviation 59.79 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 2 (n = 12, 6) | 498.50 nanogram/milliliter (ng/mL) | Standard Deviation 218.28 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 3 (n = 6, 5) | 247.40 nanogram/milliliter (ng/mL) | Standard Deviation 147.41 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 4 (n = 5, 3) | 124.67 nanogram/milliliter (ng/mL) | Standard Deviation 83.94 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 5 (n = 3, 4) | 248.25 nanogram/milliliter (ng/mL) | Standard Deviation 127.43 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 6 (n = 2, 2) | 122.50 nanogram/milliliter (ng/mL) | Standard Deviation 137.89 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 7 (n = 1, 2) | 272.50 nanogram/milliliter (ng/mL) | Standard Deviation 105.36 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 8 (n = 0, 2) | 501.00 nanogram/milliliter (ng/mL) | Standard Deviation 94.75 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 9 (n = 0, 2) | 331.00 nanogram/milliliter (ng/mL) | Standard Deviation 229.1 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 11 (n = 0, 2) | 426.50 nanogram/milliliter (ng/mL) | Standard Deviation 119.5 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 12 (n = 0, 2) | 375.50 nanogram/milliliter (ng/mL) | Standard Deviation 350.02 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 13 (n = 0, 2) | 457.50 nanogram/milliliter (ng/mL) | Standard Deviation 36.06 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 14 (n = 0, 2) | 420.00 nanogram/milliliter (ng/mL) | Standard Deviation 45.25 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 15 (n = 0, 2) | 444.50 nanogram/milliliter (ng/mL) | Standard Deviation 47.38 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 16 (n = 0, 2) | 443.50 nanogram/milliliter (ng/mL) | Standard Deviation 23.33 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 17 (n = 0, 2) | 426.00 nanogram/milliliter (ng/mL) | Standard Deviation 4.24 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 18 (n = 0, 2) | 570.50 nanogram/milliliter (ng/mL) | Standard Deviation 487.2 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 19 (n = 0, 1) | 537.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 20 (n = 0, 2) | 458.50 nanogram/milliliter (ng/mL) | Standard Deviation 239.71 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 21 (n = 0, 2) | 437.00 nanogram/milliliter (ng/mL) | Standard Deviation 21.21 |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 22 (n = 0, 1) | 401.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 23 (n = 0, 1) | 481.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 24 (n = 0, 1) | 361.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 25 (n = 0, 1) | 424.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 26 (n = 0, 1) | 366.00 nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 27 (n = 0, 0) | NA nanogram/milliliter (ng/mL) | — |
| Figitumumab 20mg/kg + Pegvisomant 20 mg | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | Cycle 10 (n = 0, 2) | 412.50 nanogram/milliliter (ng/mL) | Standard Deviation 185.97 |