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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01226316

NCT01226316
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You must be at least 18 years old.
  • For Parts A and B: You have a solid tumour cancer (not lymphoma) that has stopped responding to standard treatments, or there are no standard treatments available for your cancer.
  • For Parts C, D, E, and F: You have specific types of cancer (such as breast, ovarian, cervical, endometrial, or other solid cancers) with certain gene changes (PIK3CA, AKT1, or PTEN mutations, or related pathway changes) — please confirm which part applies to you with the trial site.
  • You have at least one tumour that can be measured and monitored using a scan (CT, MRI, or X-ray).
  • Doctors estimate you are likely to live for more than 12 weeks.

Who may not be able to join:

  • You have significant problems with how your body manages blood sugar levels.
  • You have cancer that has spread to the spine or brain, unless it has been treated, is stable, and is not causing symptoms or requiring steroid medication.
  • You have serious or uncontrolled illnesses, including active uncontrolled bleeding, or active infections such as Hepatitis B, Hepatitis C, or HIV.
  • You have significant heart problems, uncontrolled low blood pressure, reduced heart pumping function, or have recently had a major heart procedure (confirm with trial site).
  • You have previously had a serious allergic or adverse reaction to the study drug AZD5363 or a closely related drug.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
AstraZeneca
Registry
clinicaltrials_gov
Start date
1 December 2010
Est. completion
26 April 2019

Where this trial is recruiting

🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇸🇬 Singapore 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events; Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of death; Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline of laboratory data (clinical chemistry, haematology, urinalysis); Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 in terms of changes from baseline in vital signs and in electrocardiogram (ECG) parameters; Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline in electrocardio...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov