Trial Outcomes & Findings for A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer (NCT NCT00781911)

NCT ID: NCT00781911

Last Updated: 2019-09-20

Results Overview

Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)

Results posted on

2019-09-20

Participant Flow

Participants who completed the study include those who died and had progressive disease.

Participant milestones

Participant milestones
Measure	Carcinoid Tumor Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Overall Study STARTED	31	12
Overall Study Received at Least 1 Dose of Study Drug	31	12
Overall Study COMPLETED	25	4
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Carcinoid Tumor Participants with carcinoid tumor received cixutumumab 10 mg/kg intravenously (IV) over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Overall Study Adverse Event	4	4
Overall Study Withdrawal by Subject	1	2
Overall Study Physician Decision	0	2
Overall Study Sponsor Decision	1	0

Baseline Characteristics

A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carcinoid Tumor n=31 Participants Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma n=12 Participants Participants received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Total n=43 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 9.65 • n=93 Participants	61.3 years STANDARD_DEVIATION 9.85 • n=4 Participants	60.6 years STANDARD_DEVIATION 9.60 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	4 Participants n=4 Participants	21 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	8 Participants n=4 Participants	22 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants	9 Participants n=4 Participants	38 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	12 Participants n=4 Participants	42 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	31 Participants n=93 Participants	12 Participants n=4 Participants	43 Participants n=27 Participants

PRIMARY outcome

Timeframe: From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)

Population: All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4.

Outcome measures

Outcome measures
Measure	Carcinoid Tumor n=31 Participants Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma n=12 Participants Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months Binomial Distribution; Primary Analysis	45.2 percentage of participants Interval 27.3 to 64.0	41.7 percentage of participants Interval 15.2 to 72.3
Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months Kaplan-Meier Method; Secondary Analysis	54.1 percentage of participants Interval 34.2 to 70.3	61.4 percentage of participants Interval 26.6 to 83.5

SECONDARY outcome

Timeframe: From Start of Treatment Baseline to Disease Progression (Up to 18 Months)

Population: All participants who received at least one dose of study drug.

Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.

Outcome measures

Outcome measures
Measure	Carcinoid Tumor n=31 Participants Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma n=12 Participants Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)	3.2 percentage of participants Interval 0.1 to 16.7	0 percentage of participants Interval 0.0 to 26.5

SECONDARY outcome

Timeframe: From Start of Treatment Up to 18 Months

Population: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data.

Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.

Outcome measures

Outcome measures
Measure	Carcinoid Tumor n=31 Participants Participants with carcinoid tumor received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.	Islet Cell Carcinoma n=12 Participants Participants with islet cell carcinoma received cixutumumab 10 mg/kg IV over 1 hour every 2 weeks. Treatment continued until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide continued to receive the same dose and schedule of their last regimen.
Percentage of Participants With a Biochemical Response Rate Chromogranin A	0.0 percentage of participants Interval 0.0 to 13.7	22.2 percentage of participants Interval 2.8 to 60.0
Percentage of Participants With a Biochemical Response Rate Gastrin	0.0 percentage of participants Interval 0.0 to 45.9	0.0 percentage of participants Interval 0.0 to 84.2

SECONDARY outcome

Timeframe: 18 months

Population: All participants who had received at least one dose of study drug.

Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.