Trial Outcomes & Findings for Preoperative Treatment With Cetuximab and/or IMC-A12 (NCT NCT00957853)

Last Updated: 2020-03-19

Results Overview

An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three treatment arms with the use of the Wilcoxon rank sum test. Type I error of alpha=0.05 (two-sided test) used. Correlation between biomarkers and molecular response or toxicity performed in an exploratory fashion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)

Results posted on

2020-03-19

Participant Flow

A total of 16 patients were enrolled in the study; however only 15 patients were started on the trial since 1 subject withdrew consent for the study.

Participant milestones

Participant milestones
Measure	Cetuximab Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses	IMC-A12 Subjects received IMC-A12 at 6 mg/kg	Cetuximab + IMC-A12 Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
Overall Study STARTED	4	6	5
Overall Study Randomization	4	6	5
Overall Study Neoadjuvant Tx Completion	3	6	5
Overall Study COMPLETED	3	6	5
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses	IMC-A12 Subjects received IMC-A12 at 6 mg/kg	Cetuximab + IMC-A12 Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Preoperative Treatment With Cetuximab and/or IMC-A12

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=4 Participants Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses.	IMC-A12 n=6 Participants Subjects received IMC-A12 at 6 mg/kg	Cetuximab + IMC-A12 n=5 Participants Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg	Total n=15 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	4 participants n=99 Participants	6 participants n=107 Participants	5 participants n=206 Participants	15 participants n=7 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants	7 Participants n=7 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants	12 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	14 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	14 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)

Population: Due to early termination of the study, data could not be collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months post treatment start

Objective response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Cetuximab n=4 Participants Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses	IMC-A12 n=6 Participants Subjects received IMC-A12 at 6 mg/kg	Cetuximab + IMC-A12 n=5 Participants Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
Number of Participants With Objective Response Stable Disease/No Change	3 Participants	4 Participants	5 Participants
Number of Participants With Objective Response Progressive Disease	0 Participants	2 Participants	0 Participants
Number of Participants With Objective Response Inevaluable	1 Participants	0 Participants	0 Participants

Adverse Events

Cetuximab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

IMC-A12

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cetuximab + IMC-A12

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cetuximab n=4 participants at risk Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses	IMC-A12 n=6 participants at risk Subjects received IMC-A12 at 6 mg/kg	Cetuximab + IMC-A12 n=5 participants at risk Subjects received Cetuximab at 400 mg/m2 loading dose and 250 mg/m2 subsequently for 1-2 doses. Subjects received IMC-A12 at 6 mg/kg
Skin and subcutaneous tissue disorders Acneiform rash	25.0% 1/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	20.0% 1/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
Skin and subcutaneous tissue disorders Dry Skin	25.0% 1/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
General disorders Fatigue	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	16.7% 1/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
General disorders Fever without Neutropenia	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	20.0% 1/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
General disorders Hot flashes	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	16.7% 1/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
Gastrointestinal disorders Mucositis-symptomatic	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	20.0% 1/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
Gastrointestinal disorders Nausea	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	33.3% 2/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
General disorders Pain(headache)	50.0% 2/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	20.0% 1/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE
General disorders Rigors/Chills	0.00% 0/4 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	0.00% 0/6 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE	20.0% 1/5 • Mortality and SAE's were assessed from the first dose of study treatment to 30 days following the last dose of drug. Adverse events were assessed according to the CTCAE

Additional Information

Dr. Maura Gillison, PHD/Professor, Thoracic-Head & Neck Med Onc

UT MD Anderson Cancer Center

Phone: 713-792-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place