# A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors

> **NCT04029688** · PHASE1,PHASE2 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 38 (actual)

## Conditions studied

- Acute Myeloid Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Neuroblastoma
- Solid Tumors

## Interventions

- **DRUG:** Idasanutlin
- **DRUG:** Venetoclax
- **DRUG:** Cyclophosphamide
- **DRUG:** Topotecan
- **DRUG:** Fludarabine
- **DRUG:** Cytarabine
- **DRUG:** Intrathecal Chemotherapy

## Key facts

- **NCT ID:** NCT04029688
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-01-27
- **Primary completion:** 2024-05-06
- **Final completion:** 2024-05-06
- **Target enrollment:** 38 (ACTUAL)
- **Why stopped:** Study was terminated by the sponsor based on insufficient tolerability and efficacy to proceed beyond Part 1b.
- **Last updated:** 2024-12-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04029688

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04029688, "A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04029688. Licensed CC0.

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