Trial Outcomes & Findings for Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer (NCT NCT01504477)

NCT ID: NCT01504477

Last Updated: 2020-03-16

Results Overview

The maximum tolerated dose of bortezomib (to be used in combination with panitumumab)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

12 months

Results posted on

2020-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Combination of Panitumumab and Bortezomib IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Panitumumab and Bortezomib for Patients With Advanced Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Age, Continuous	60.83 years STANDARD_DEVIATION 5.27 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The maximally tolerated dose of bortezomib weekly to be used in combination with with Panitumumab every 2 weeks

The maximum tolerated dose of bortezomib (to be used in combination with panitumumab)

Outcome measures

Outcome measures
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Maximum Tolerated Dose	1.6 mg/m2

PRIMARY outcome

Timeframe: 12 months

Population: The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)

The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)

Outcome measures

Outcome measures
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Maximum Tolerated Dose	6 mg/kg

SECONDARY outcome

Timeframe: 16 weeks

Stable disease after 2 cycles, partial response or complete response as determined by RECIST v1.0

Outcome measures

Outcome measures
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Percent of Patients With Disease Control	0 percentage of participants

SECONDARY outcome

Timeframe: 16 weeks

Partial response plus complete response as per RECIST v1.0

Outcome measures

Outcome measures
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Percent of of Patients With a Complete or Partial Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

Time from study registration until progressive disease

Outcome measures

Outcome measures
Measure	Combination of Panitumumab and Bortezomib n=6 Participants IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Duration of Disease Control	35.5 Days Interval 8.0 to 47.0

Adverse Events

Combination of Panitumumab and Bortezomib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Combination of Panitumumab and Bortezomib n=6 participants at risk IV panitumumab and bortezomib Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle. Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
General disorders fatigue	33.3% 2/6
Skin and subcutaneous tissue disorders Rash	16.7% 1/6
Gastrointestinal disorders Diarrhea	16.7% 1/6
Investigations Electrolyte	16.7% 1/6
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6

Additional Information

Michael Pishvaian

Georgetown University

Phone: 202-444-2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place