Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma (NCT NCT01592383)

NCT ID: NCT01592383

Last Updated: 2018-10-16

Results Overview

Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Treatment (Enzyme Inhibitor Therapy) Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment (Enzyme Inhibitor Therapy) Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	1

Baseline Characteristics

Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma

Baseline characteristics by cohort

Measure	Treatment (Enzyme Inhibitor Therapy) n=2 Participants Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	55 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

Progression free survival (PFS) defined as time from study enrollment until disease progression or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

Overall survival measured as the time from study enrollment until death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days from the last dose of study drug

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: The study was terminated early after the enrollment of two participants and the data were not collected.

EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Enzyme Inhibitor Therapy)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Enzyme Inhibitor Therapy) n=2 participants at risk Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • Number of events 2 • 1 year An expected mild skin rash
General disorders Fatigue	50.0% 1/2 • Number of events 2 • 1 year An expected mild skin rash
General disorders Constipation	50.0% 1/2 • Number of events 2 • 1 year An expected mild skin rash

Additional Information

Hedy Kindler

University of Chicago

Phone: 7737020360

Email: hkindler@medicine.bsd.uchicago.edu

Results disclosure agreements

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