NCT02826642 is a Phase 1 clinical trial of IDH305 in Acute Myeloid Leukemia (AML), sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02826642?

NCT02826642 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02826642?

Interventions in NCT02826642: IDH305.

What condition does NCT02826642 study?

NCT02826642 studies Acute Myeloid Leukemia (AML).

Is NCT02826642 still recruiting?

NCT02826642 is currently withdrawn. Last updated 10 April 2019.

Last reviewed 2019-04-10 · How we verify

NCT02826642

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Withdrawn Phase 1 Last updated 10 April 2019

What this trial tests

Phase 1 trial testing IDH305 in Acute Myeloid Leukemia (AML). Withdrawn.

Timeline

26 August 2016

Primary endpoint
29 November 2016

29 November 2016

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	26 August 2016
Primary completion	29 November 2016
Estimated completion	29 November 2016

Drugs / interventions tested

IDH305 — full drug profile →

Conditions studied

Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
Consequences of <i>IDH1/2</i> Mutations in Gliomas and an Assessment of Inhibitors Targeting Mutated IDH Proteins.
Kaminska B, Czapski B, Guzik R, Król SK, et al · · 2019 · cited 78× · PMID 30857299 · DOI 10.3390/molecules24050968
<i>IDH1</i>-mutated relapsed or refractory AML: current challenges and future prospects.
Megías-Vericat JE, Ballesta-López O, Barragán E, Montesinos P. · · 2019 · cited 28× · PMID 31413655 · DOI 10.2147/blctt.s177913
Biological Roles and Therapeutic Applications of IDH2 Mutations in Human Cancer.
Guo J, Zhang R, Yang Z, Duan Z, et al · · 2021 · cited 25× · PMID 33981605 · DOI 10.3389/fonc.2021.644857
Targeting IDH1 and IDH2 Mutations in Acute Myeloid Leukemia: Emerging Options and Pending Questions.
Wouters BJ. · · 2021 · cited 10× · PMID 34095766 · DOI 10.1097/hs9.0000000000000583
Novel small-molecule therapies for myelodysplastic syndromes with IPSS-R ⩾3.5 in patients aged 60 or older: current landscape and challenges.
Hou K, Dong X, Niu W. · · 2025 · cited 1× · PMID 40919259 · DOI 10.1177/20406207251371298

Verify or expand the search:

Other trials of IDH305

Trials testing the same drug.

NCT02381886 — A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations · Phase 1 · active not recruiting

Other recruiting trials for Acute Myeloid Leukemia (AML)

Currently open trials in the same condition.

NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02826642 (US National Library of Medicine, public domain)
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 Novartis Pharmaceuticals
Last refreshed: 10 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02826642.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing