Clinical trial · Interventional
AT7519M in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory Non-Hodgkin's Lymphoma
A Phase I Study of AT7519M Given Twice Weekly in Patients With Advanced Incurable Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: AT7519M may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDKI AT7519 | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CDKI AT7519
- description
- AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
- interventionNames
- Drug: CDKI AT7519
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Maximum tolerated dose as assessed by NCI CTCAE v.30
- timeFrame
- from time of 1st dose
- measure
- Safety, tolerability, toxicity profile, and dose-limiting toxicities as assessed by NCI CTCAE v.30
- timeFrame
- from time of 1st dose
- measure
- Pharmacokinetic profile as measured on days 1, 2, and 4 in course 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following:
* Advanced and/or metastatic solid tumor
* No more than 3 prior regimens for metastatic disease
* Refractory non-Hodgkin's lymphoma
* Clinically or radiologically documented disease
* Patients whose only evidence of disease is tumor marker elevation are not eligible
* No untreated brain or meningeal metastases
* Patients with radiologic or clinical evidence of stable, treated brain metastases are eligible provided they are asymptomatic AND have no requirement for corticosteroids
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.25 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
* Bilirubin normal
* ALT and AST ≤ 2 times ULN (5 times ULN if patient has documented liver metastases)
* Potassium normal
* Calcium normal
* Creatine kinase (CK or CPK) ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
* Significant cardiac event (including symptomatic heart failure or angina) within the past 3 months or any cardiac disease that, in the opinion of the investigator, increases the risk for ventricular arrhythmia
* Any history of ventricular arrhythmia, which was symptomatic or required treatment (CTC grade 3), including multifocal PVCs, bigeminy, trigeminy, or ventricular tachycardia
* Uncontrolled hypertension
* Previous history of QT prolongation with other medication
* Congenital long QT syndrome
* QT and QTc, with Bazett's correction, unmeasurable or ≥ 460 msec on screening ECG
* LVEF \< 45 % by MUGA for patients with significant cardiac history (i.e., myocardial infarction, severe hypertension, or arrhythmia) or prior doxorubicin (\> 450 mg/m²)
* No active or uncontrolled infections
* No serious illness or medical condition that would preclude study compliance
* No peripheral neuropathy \> grade 1
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 21 days since prior cytotoxic chemotherapy and recovered (solid tumors)
* At least 21 days since prior palliative radiotherapy and recovered
* Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy
* Prior hormonal, immunologic, biologic, or signal transduction inhibitor therapy allowed
* At least 14 days since prior major surgery and recovered (no nonhealing wounds)
* At least 4 weeks since prior steroids
* No other concurrent medications which affect QT/QTc and cannot be discontinued
* No other concurrent experimental drugs or anticancer therapyReferences
Publications (2)
- RESULTChen EX, Hotte S, Hirte H, Siu LL, Lyons J, Squires M, Lovell S, Turner S, McIntosh L, Seymour L. A Phase I study of cyclin-dependent kinase inhibitor, AT7519, in patients with advanced cancer: NCIC Clinical Trials Group IND 177. Br J Cancer. 2014 Dec 9;111(12):2262-7. doi: 10.1038/bjc.2014.565. Epub 2014 Nov 13. PMID 25393368
- DERIVEDMalumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602. PMID 19238148