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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

NCTNCT00976508 (opens ClinicalTrials.gov in a new tab)Other idA4021040
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
4 countries

United States, Canada, Finland, Germany

Start
Nov 2009
Primary completion
Sept 2011
Completion
Oct 2012
First posted
14 Sept 2009 (estimated)
Last update posted
13 Dec 2013 (estimated)
Conditions
Colorectal Neoplasms · Lung Neoplasms · Breast Neoplasms · Prostatic Neoplasms · Sarcoma

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 1

    Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

    NCT00976508

    Nov 2009 to Oct 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

Interventions

  • figitumumabDrug
  • pegvisomantDrug

Arms1

  • Experimental

    1

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame · From Screening to the follow-up visit (90 days after last dose of figitimumab)

    Registry description

    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.

  2. Number of Participants With Dose Limiting Toxicities (DLT)

    Time frame · From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2

    Registry description

    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 outcomes(11)

  1. Serum Circulating Insulin-like Growth Factor (IGF-1) Levels

    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)

    Registry description

    The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.

  2. 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

  3. 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

  4. 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

  5. Plasma Concentration at the Last Quantifiable Time Point (Clast) 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

    Registry description

    Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.

  6. Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab

    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)

    Registry description

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.

  7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)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

    Registry description

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1

  8. Area Under the Trough Concentrations (AUCtrough)

    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

    Registry description

    The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.

  9. Mean Change in Glucose Levels Between Fasting and Post Glucose Load

    Time frame · Screening; Day 8 of Cycle 1; Day 15 of Cycle 2

    Registry description

    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.

  10. Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response 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)

    Registry description

    Percentage of participants with positive total or neutralizing ADA for figitumumab.

  11. Number of Participants With Objective 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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From Screening to the follow-up visit (90 days after last dose of figitimumab)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

GroupValue (Participants)
Figitumumab 20mg/kg + Pegvisomant 10 mg17
Figitumumab 20mg/kg + Pegvisomant 20 mg6
Primary outcomeNumber· From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2

Number of Participants With Dose Limiting Toxicities (DLT)

GroupValue (participants)
Figitumumab 20 mg/kg + Pegvisomant 10 mg1
Figitumumab 20mg/kg + Pegvisomant 20 mg0
Secondary and other outcome results(6)
Secondary outcomeMean· 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)

Serum Circulating Insulin-like Growth Factor (IGF-1) Levels

GroupValue (nanogram/milliliter (ng/mL))Spread
Figitumumab 20 mg/kg + Pegvisomant 10 mg150.1877.06
Figitumumab 20mg/kg + Pegvisomant 20 mg189.1759.79
Secondary outcome· Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15

Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab

GroupValue
Figitumumab 20 mg/kg + Pegvisomant 10 mgnot posted
Figitumumab 20mg/kg + Pegvisomant 20 mgnot posted
Secondary outcome· 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

Maximum Observed Plasma Concentration (Cmax) of Figitumumab

GroupValue
Figitumumab 20 mg/kg + Pegvisomant 10 mgnot posted
Figitumumab 20mg/kg + Pegvisomant 20 mgnot posted
Secondary outcome· Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15

Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab

GroupValue
Figitumumab 20 mg/kg + Pegvisomant 10 mgnot posted
Figitumumab 20mg/kg + Pegvisomant 20 mgnot posted
Secondary outcome· 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

GroupValue
Figitumumab 20 mg/kg + Pegvisomant 10 mgnot posted
Figitumumab 20mg/kg + Pegvisomant 20 mgnot posted
Secondary outcome· 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)

Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab

GroupValue
Figitumumab 20 mg/kg + Pegvisomant 10 mgnot posted
Figitumumab 20 mg/kg + Pegvisomant 20 mgnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Figitumumab 20 mg/kg + Pegvisomant 10 mgFigitumumab 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.–9 / 1717 / 17
Figitumumab 20 mg/kg + Pegvisomant 20 mgFigitumumab 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 total duration of 27 cycles). 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 total duration of 27 cycles. Each cycle was of 21 days.–4 / 66 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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