Trial Outcomes & Findings for A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors (NCT NCT01962896)

NCT ID: NCT01962896

Last Updated: 2019-02-26

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions or the development of any new lesions

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib + Sirolimus Erlotinib 85 mg/m2, max of 150 mg, was administered orally once daily continuously. Intrapatient dose escalation and de-escalation rules provided in the protocol. Sirolimus was started at a dose of 1 mg/m2, maximum 2mg, orally once daily continuously. The dose of sirolimus was be adjusted at least weekly to obtain a goal trough level of 10-15ng/mL.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib + Sirolimus Erlotinib 85 mg/m2, max of 150 mg, was administered orally once daily continuously. Intrapatient dose escalation and de-escalation rules provided in the protocol. Sirolimus was started at a dose of 1 mg/m2, maximum 2mg, orally once daily continuously. The dose of sirolimus was be adjusted at least weekly to obtain a goal trough level of 10-15ng/mL.
Overall Study Lack of Efficacy	4

Baseline Characteristics

A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib + Sirolimus n=4 Participants Erlotinib Sirolimus
Age, Categorical <=18 years	3 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Erlotinib + Sirolimus n=4 Participants Erlotinib Sirolimus
The PFR, Defined as the Proportion of Patients With Refractory Germ Cell Tumors Free of Objective Disease Progression After 4 Cycles (16 Weeks) of Therapy With Erlotinib and Sirolimus	0 percentage of patients

PRIMARY outcome

Timeframe: 2 years

The number of patients with drug related grade III, IV, or V adverse events according to the Common Terminology Criteria for Adverse Events version 4.0.

Outcome measures

Outcome measures
Measure	Erlotinib + Sirolimus n=4 Participants Erlotinib Sirolimus
The Toxicities of the Combination of Sirolimus and Erlotinib Administered on This Schedule. No CTCAE v4 Grade >2 AE	2 Participants
The Toxicities of the Combination of Sirolimus and Erlotinib Administered on This Schedule. CTCAE v4 grade 3 AE	2 Participants
The Toxicities of the Combination of Sirolimus and Erlotinib Administered on This Schedule. CTCAE v4 grade 4 AE	0 Participants
The Toxicities of the Combination of Sirolimus and Erlotinib Administered on This Schedule. CTCAE v4 grade 5 AE	0 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Analysis was not performed as the study was terminated early without sufficient enrollment to analyze this objective.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Analysis was not performed as the study was terminated early without sufficient enrollment to analyze this objective.

Outcome measures

Outcome data not reported

Adverse Events

Erlotinib + Sirolimus

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Erlotinib + Sirolimus n=4 participants at risk Erlotinib Sirolimus
Skin and subcutaneous tissue disorders Rash	100.0% 4/4 • AEs were collected from enrollment until the patient came off study, up to 2 years
Gastrointestinal disorders Mucositis oral	50.0% 2/4 • AEs were collected from enrollment until the patient came off study, up to 2 years
Hepatobiliary disorders Aspartate aminotransferase increased	50.0% 2/4 • AEs were collected from enrollment until the patient came off study, up to 2 years
Hepatobiliary disorders Alanine aminotransferrase increased	50.0% 2/4 • AEs were collected from enrollment until the patient came off study, up to 2 years

Additional Information

Theodore Laetsch, MD

University of Texas Southwestern Medical Center

Phone: 214-648-5475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place