Trial Outcomes & Findings for Study of SNX-5422 in TP53 Null Cancers (NCT NCT02612285)

Results Overview

Effect of SNX-5422 on tumor progression. Complete remissions plus partial remissions plus stable disease at ≥6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or appropriate hematological malignancy criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2018-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	SNX-5422 Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422. SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SNX-5422 Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422. SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of SNX-5422 in TP53 Null Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SNX-5422 n=1 Participants Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422. SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Subject withdrew from study before any data points gathered

Effect of SNX-5422 on tumor progression. Complete remissions plus partial remissions plus stable disease at ≥6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or appropriate hematological malignancy criteria.

Outcome measures

Outcome data not reported

Adverse Events

SNX-5422

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Orlemans PhD

Esanex Inc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place