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

NCT00862355

NCT00862355
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You must be available for the full length of the study and willing to follow all study requirements.
  • You must have an official diagnosis of ovarian cancer and be suitable to receive a specific dose of a drug called liposomal doxorubicin.
  • You must be 18 years of age or older.
  • You must have no significant other health conditions found during screening, with a physical check-up completed within 21 days before the study begins.
  • You must score 2 or lower on a standard scale that measures how much your illness affects your daily activities (confirm with trial site).
  • Your blood test results at screening must be within normal ranges, or considered not medically significant by the study doctor.
  • You must be willing and able to sign a written consent form agreeing to take part.

Who may not be able to join:

  • You have had a significant allergic or unusual reaction to doxorubicin or similar medicines in the past.
  • You have a significant history of heart, lung, liver, kidney, stomach, hormone, immune system, skin, muscle, nerve, or mental health conditions.
  • You have had a problem with alcohol or drug misuse or addiction in the past year.
  • You have had a significant illness (other than ovarian cancer) in the 4 weeks before the study starts.
  • You have tested positive for HIV, hepatitis C, hepatitis B, or syphilis.
  • You have taken certain medicines that affect how the body processes drugs (such as Phenytoin, Carbamazepine, or Barbiturates) in the 30 days before or during the study.
  • You have donated 350 mL or more of blood in the 90 days before the study starts.
  • You have taken part in another clinical trial in the 90 days before this study starts.
  • Your blood pressure or pulse rate falls outside the acceptable ranges set by the study (confirm with trial site).

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
Sun Pharma Advanced Research Company Limited
Registry
clinicaltrials_gov
Start date
1 March 2010
Est. completion
1 December 2010

Where this trial is recruiting

🇮🇳 India

Primary endpoints

90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product

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