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Colorectal NeoplasmsPhase 1NCT00976508

Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

A Phase 1 study testing figitumumab and pegvisomant in people with Colorectal Neoplasms and Lung Neoplasms, run by Pfizer at 5 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 10 years and older
What is being tested?
figitumumab and pegvisomant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesin 4 countries
Study dates
Nov 2009to Oct 2012
Phase
Phase 1
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 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

United States2 sites

  • Pfizer Investigational Site

    Minneapolis, Minnesota, 55455

  • Pfizer Investigational Site

    Rochester, Minnesota, 55905

Other trials in United States

Canada1 site

  • Pfizer Investigational Site

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Finland1 site

  • Pfizer Investigational Site

    Helsinki, 00290

Other trials in Finland

Germany1 site

  • Pfizer Investigational Site

    Münster, 48149

Other trials in Germany

About this study

Official title: Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors

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

Read the 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.

Being tested
figitumumab, pegvisomant
Keywords
advanced solid tumors cancer refractory cancer figitumumab pegvisomant
Medical subject headings
Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • figitumumabDrug

    Also called CP-751,871

    IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year

  • pegvisomantDrug

    Also called Somavert

    growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year

Study groups in NCT00976508
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: figitumumab; Drug: pegvisomant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Screening to the follow-up visit (90 days after last dose of figitimumab)

  2. 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.

    Measured: From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2

Secondary outcomes (11)

  1. 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.

    Measured: 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)

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

    Measured: 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

    Measured: 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

    Measured: 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

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

    Measured: 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

  6. 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.

    Measured: 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)

  7. 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

    Measured: 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

  8. Area Under the Trough Concentrations (AUCtrough)

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

    Measured: 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

  9. 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.

    Measured: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2

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

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

    Measured: 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)

  11. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionSep 2011
  4. Study completionOct 2012

Why it stopped: See termination reason in detailed description.

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976508
Sponsor's protocol ID
A4021040
Status last verified
Oct 2013
First submitted
10 Sep 2009
Last updated
13 Dec 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing figitumumab and pegvisomant in people with Colorectal Neoplasms and Lung Neoplasms, run by Pfizer at 5 sites in 4 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada, Finland, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 13 Dec 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?

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)). The study lists 2 primary outcomes in all. 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 NCT00976508.

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 13 Dec 2013.

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