Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Sarcoma
Interventions:	Drug: figitumumab; Drug: pegvisomant

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Figitumumab 20mg/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.
Figitumumab 20mg/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.

Participant Flow:   Overall Study

	Figitumumab 20mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
STARTED	17 [1]	6
COMPLETED	3 [2]	0
NOT COMPLETED	14	6
Death	7	1
Lost to Follow-up	1	0
Withdrawal by Subject	1	0
Disease Progression	4	4
Subject Enrolled in Hospice	1	0
Terminated by the Sponsor	0	1

[1]	18 subjects were enrolled; 17 subjects were treated; 1 subject was not eligible.
[2]	These subjects withdrew from last study treatment due to progressive disease.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Figitumumab 20 mg/kg +Pegvisomant 10 mg	Figitumumab 20 mg/kg + Pegvisomant 20 mg	Total
Overall Participants Analyzed; [Units: Participants]	17	6	23
Age; [Units: Years]; Mean (Standard Deviation)	49.5 (17.4)	32.3 (9.8)	45.0 (17.4)
Gender; [Units: Participants]
Female	8	5	13
Male	9	1	10

  Outcome Measures

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1. Primary:

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) ]

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2. Primary:

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 ]

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3. Secondary:

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) ]

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4. 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 ]

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5. 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 ]

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6. 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 ]

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7. Secondary:

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 ]

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8. Secondary:

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) ]

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9. Secondary:

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 ]

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10. Secondary:

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 ]

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11. Secondary:

Mean Change in Glucose Levels Between Fasting and Post Glucose Load [ Time Frame: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2 ]

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12. Secondary:

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) ]

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13. Secondary:

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) ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact:  

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00976508 History of Changes
Other Study ID Numbers:	A4021040
First Submitted:	September 10, 2009
First Posted:	September 14, 2009
Results First Submitted:	October 23, 2013
Results First Posted:	December 13, 2013
Last Update Posted:	December 13, 2013