# Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

> **NCT01226316** · PHASE1 · COMPLETED · sponsor: **AstraZeneca** · enrollment: 285 (actual)

## Conditions studied

- Advanced Solid Malignancy
- Safety and Tolerability
- Pharmacokinetics
- Pharmacodynamics
- Tumour Response
- Advanced or Metastatic Breast Cancer
- Ovarian Cancer
- Cervical Cancer
- Endometrial Cancer
- PIK3CA
- AKT1
- PTEN
- ER Positive
- HER2 Positive

## Interventions

- **DRUG:** AZD5363
- **DRUG:** AZD5363
- **DRUG:** AZD5363
- **DRUG:** AZD5363

## Key facts

- **NCT ID:** NCT01226316
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-12-01
- **Primary completion:** 2019-04-26
- **Final completion:** 2024-12-03
- **Target enrollment:** 285 (ACTUAL)
- **Last updated:** 2025-06-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01226316

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01226316, "Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT01226316. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*