Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)
TerminatedPhase 1, PHASE2Results postedLast updated 17 April 2019
What this trial tests
Phase 1, PHASE2 trial testing Entospletinib in Non-Hodgkin Lymphoma in 10 participants. Terminated before completion.
18 and older, any sex, with Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs) and Laboratory (Lab) Abnormalities Defined as Dose Limiting Toxicities (DLTs) in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation StagePrimary· Cycle 1 (28-day cycle)
Occurrence of any of the following toxicities during Cycle 1 was considered DLT if judged by the Investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen:
* Grade 4 (or higher) non-hematologic toxicity
* Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care
* Note: Grade 3 or higher neuropathy was considered DLT if occurring during Cycle 1 regardless of duration.
* Any Grade 3 non-hematologic laboratory value if:
* Medical intervention was required to treat the patient, or
* Abnormality led to h
Group
Value
95% CI
ENTO 200 mg
0
ENTO 400 mg
2
Number of Participants With AEs and Lab Abnormalities Not Defined as DLTs in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation StageSecondary· Cycle 1 (28-day cycle)
The number of participants with AEs and lab abnormalities not defined as DLTs in participants in the dose escalation stage with relapsed or refractory B-cell NHL are presented.
AEs not defined as DLTs
Group
Value
95% CI
ENTO 200 mg
6
ENTO 400 mg
4
Lab abnormalities not defined as DLTs
Group
Value
95% CI
ENTO 200 mg
5
ENTO 400 mg
4
Duration of Exposure to ENTOSecondary· Baseline to end of study (maximum: 24 weeks)
Group
Value
95% CI
ENTO 200 mg
17.7
± 6.09
ENTO 400 mg
4.3
± 2.68
Number of VCR DosesSecondary· Baseline to end of study (maximum: 24 weeks)
Group
Value
95% CI
ENTO 200 mg
8.7
± 3.27
ENTO 400 mg
2.3
± 1.50
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to the last dose date plus 30 days (maximum exposure: 200 mg ENTO = 24 weeks; 400 mg ENTO = 8 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 17 April 2019
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