Trial · NCT02835729
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety assessed by development of RLT, AEs and laboratory parameters of indoximod. | 6 months | Phase 1 |
| Primary | Comparison of serum concentrations (Cmax/Steady State) of indoximod freebase and indoximod salt formulation. | 6 months | Phase 1 |
| Secondary | Measurable Residual Disease Rate | 2 years | |
| Secondary | Clinical response rate | 2 years | |
| Secondary | Duration of complete response | 2 years | |
| Secondary | Event free survival | 2 years | Time on study to induction failure, relapse or death |
| Secondary | Cumulative incidence of relapse (CIR) | 2 years | |
| Secondary | Overall survival (OS) | 2 years | |
| Secondary | Proportion of AML patients who become eligible for bone marrow transplantation | 2 years | |
| Secondary | Frequency and severity of adverse events | 2 years | |
| Secondary | Pharmacokinetics: Serum concentrations (Cmax/Steady State) | 6 months | Characterize the pharmacokinetics (PK) of indoximod, idarubicin and cytarabine through analysis of blood samples |
| Other | Serum kynurenine and tryptophan levels | 2 years | Characterize the pharmacodynamic (PD) effect of indoximod |
| Other | IDO expression by immunohistochemistry in diagnostic and follow-up bone marrow biopsy specimens | 2 years | |
| Other | IDO protein and mRNA expression in diagnostic and follow-up bone marrow aspirate samples | 2 years | |
| Other | Methylation status of the IDO promoter in diagnostic and follow up bone marrow aspiration samples | 2 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02835729/registered