Trial Outcomes & Findings for Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma (NCT NCT03213626)

NCT ID: NCT03213626

Last Updated: 2020-08-27

Results Overview

Percent of patients with Objective response and the Binomial Exact 95% confidence interval. Objective response is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) by RECIST v1.1 criteria.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-08-27

Participant Flow

This was a single arm two stage design. The 1st stage was to have 11 patients and be terminated if 0 responded. The 2nd stage would have a total of 37 patients and if the number responding was <= 2, the combination was to be rejected. The study was terminated prematurely due to no patient benefit at Patient 7.

Participant milestones

Measure	Cabozantinib + Erlotinib Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Cabozantinib + Erlotinib Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Overall Study Adverse Event	1
Overall Study Progressive Disease	6

Baseline Characteristics

Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	63.2 years STANDARD_DEVIATION 8.36 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
ECOG Performance Status 0-Fully active	4 Participants n=5 Participants
ECOG Performance Status 1-Restricted in physically strenuous activity	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of treatment

Percent of patients with Objective response and the Binomial Exact 95% confidence interval. Objective response is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) by RECIST v1.1 criteria.

Outcome measures

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Objective (Radiographic) Response	0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All patients who received at least one dose of treatment

Percent of patients achieving disease control and the Binomial Exact 95% confidence interval. Disease control is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) or Stable Disease for at least 4 months (defined by neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression) by RECIST v1.1 criteria.

Outcome measures

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Disease Control Rate	0 percentage of participants There were no patients achieving disease control rate and the confidence interval was not calculated.

SECONDARY outcome

Timeframe: 2 years

Population: All patients who received at least one dose of treatment

Duration of time from the start of treatment to time of documented progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients who do not progress or die will be censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

Outcome measures

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Progression Free Survival	1.8 months Interval 0.7 to 1.9

SECONDARY outcome

Timeframe: 2 years

Population: All patients who received at least one dose of treatment

Duration of time from the start of treatment to time of death due to any causes. Patients who do not die will be censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

Outcome measures

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Overall Survival	7.7 months Interval 2.1 to 12.0

SECONDARY outcome

Timeframe: Up to 5 months

Population: All patients who received at least one dose of treatment

Number of unique patients who had a treatment related (possible, probable or definite) adverse events with grade >= 3.

Outcome measures

Measure	Cabozantinib + Erlotinib n=7 Participants Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Treatment Related Adverse Events Grade 3 or Above	2 Participants

Adverse Events

Cabozantinib + Erlotinib

Serious events: 2 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Measure	Cabozantinib + Erlotinib n=7 participants at risk Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Infections and infestations Biliary tract infection	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.

Other adverse events

Measure	Cabozantinib + Erlotinib n=7 participants at risk Cabozantinib 40 MG: To be taken orally once daily Erlotinib 100Mg Tab: To be taken orally once daily
Gastrointestinal disorders Abdominal distension	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Constipation	28.6% 2/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Diarrhea	85.7% 6/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Gastroesophageal reflux disease	28.6% 2/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Nausea	57.1% 4/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
General disorders Fatigue	42.9% 3/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
General disorders Fever	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Infections and infestations Urinary tract infection	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Investigations Aspartate aminotransferase increased	42.9% 3/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Metabolism and nutrition disorders Anorexia	28.6% 2/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Musculoskeletal and connective tissue disorders Chest wall pain	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Psychiatric disorders Anxiety	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Psychiatric disorders Insomnia	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Skin and subcutaneous tissue disorders Rash acneiform	42.9% 3/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Vascular disorders Hypertension	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.
Vascular disorders Thromboembolic event	14.3% 1/7 • Up to 5 months for Adverse Events (Serious and Other). Up to 2 years for All Cause Mortality.

Additional Information

Dr. Patrick Loehrer

IndianaU

Phone: (317) 278-7418

Email: ploehrer@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place