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NCT02835729 · ClinicalTrials.gov registry record · Phase 1

A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study, sponsored by NewLink Genetics Corporation.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target

NCT02835729 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 54 participants.

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The verdict

NCT02835729, a Phase 1 study, has completed, sponsored by NewLink Genetics Corporation.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

Study Summary

The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.

Interventions

  • DRUG Cytarabine
  • DRUG Idarubicin
  • DRUG Indoximod Freebase
  • DRUG Indoximod HCL F1
  • DRUG Indoximod HCL F2

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2016-07
Est. Completion 2019-12-27
Phase Phase 1

Sponsor

NewLink Genetics Corporation

31 total trials

What the Registry Record Tells You About NCT02835729

The ClinicalTrials.gov registry entry for NCT02835729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.

NCT02835729 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02835729 about?

NCT02835729 is a clinical study titled "A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia". The purpose of this study is to characterize the regimen limiting toxicities (RLT) and recommended Phase 2 dose (RP2D) of indoximod in patients with newly diagnosed AML receiving remission induction chemotherapy with cytarabine and idarubicin.

What is the current status of trial NCT02835729?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2016-07. Estimated completion is 2019-12-27.

What interventions are being tested in trial NCT02835729?

The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Indoximod Freebase (DRUG), Indoximod HCL F1 (DRUG), Indoximod HCL F2 (DRUG).

Who is sponsoring clinical trial NCT02835729?

This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.