Phase 2 Ovarian Cancer Trial, Completed NCT00058552 Sponsor: Genentech, Inc. Condition: Ovarian Cancer
Back to Ovarian Cancer

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people with cancer — 65 in a group receiving a lower dose of pertuzumab (420 mg) and 64 in a group receiving a higher dose (1050 mg). The trial was measuring how participants' tumours responded to two different doses of pertuzumab, using either tumour size measurements or a blood marker called CA-125 to track changes. Almost none of the participants completed the study in the usual sense — 65 from the lower-dose group and 62 from the higher-dose group did not complete it, for reasons the data does not detail further. The reported data shows that very few participants saw their tumours shrink. In the lower-dose group, 3.6% of participants had a meaningful reduction in tumour size or marker levels (what researchers call a complete or partial response), compared to 4.8% in the higher-dose group. For those who did respond, the reported duration of that response was around 18.6 weeks in the lower-dose group and 21.1 weeks in the higher-dose group. Looking at disease progression or death during the study, the reported data shows 89.1% of the lower-dose group and 75.8% of the higher-dose group experienced one of these events. The median time before disease progression or death was reported as 7.6 weeks in the lower-dose group and 6.1 weeks in the higher-dose group. Overall survival figures were reported as 46.7 weeks for the lower-dose group; for the higher-dose group, this figure was listed as not available in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Ovarian Cancer Trial, Completed

NCT00058552
Completed Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You are willing to sign a consent form agreeing to take part in the study
  • You are willing to have a tumor biopsy taken, and your tumor is in a location that can be safely biopsied (first group of participants only)
  • You are 18 years of age or older
  • You have been diagnosed with advanced ovarian cancer confirmed by laboratory tissue testing
  • You have measurable tumors — either at least one tumor large enough to be measured by standard scans (at least 20mm on regular scans, or at least 10mm on a spiral CT scan), OR you have disease visible on scans or exams (such as fluid buildup or deposits) along with two blood test results (CA-125) taken at least one week apart showing levels more than twice the lab's upper normal limit and at least 40 IU/mL
  • You have previously received at least one chemotherapy treatment containing a platinum-based drug (such as carboplatin or cisplatin) for your ovarian cancer
  • Doctors expect you to live for at least 12 weeks or more
  • You are generally able to carry out daily activities with little or no difficulty (confirm with trial site regarding the specific activity scale used)
  • You are using effective birth control if there is any chance you could become pregnant
  • Your blood counts are at acceptable levels — enough white blood cells, platelets, and red blood cells (transfusions or growth factor support are allowed to meet this requirement)
  • Your liver function blood tests are within acceptable ranges
  • Your kidney function blood test is within an acceptable range
  • Your blood clotting tests are within acceptable ranges (unless you are already taking warfarin)

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have received any experimental cancer treatment within the 4 weeks before the first dose of the study drug
  • You have ever been treated with certain drugs that target a specific cancer pathway called HER, such as Herceptin (trastuzumab), Iressa, or Tarceva
  • You have a history of cancer that has spread to your brain or spinal fluid
  • Your heart's pumping function (ejection fraction) is below 50% on an echocardiogram (heart ultrasound)
  • You have uncontrolled high calcium levels in your blood
  • You have previously received high cumulative doses of certain chemotherapy drugs including doxorubicin, liposomal doxorubicin, mitoxantrone, or idarubicin (confirm specific limits with trial site)
  • You have been diagnosed with another cancer within the past 5 years, except for certain early-stage or skin cancers that have been fully treated (such as cervical carcinoma in situ, ductal carcinoma in situ of the breast, or basal/squamous cell skin cancer)
  • You have serious ongoing health conditions such as an active infection, poorly controlled high blood pressure, unstable chest pain, heart failure, or a heart attack within the past 6 months, or an uncontrolled irregular heartbeat requiring medication
  • You have active liver disease, including hepatitis, current alcohol misuse, or cirrhosis
  • You have a known HIV infection
  • You are currently pregnant or breastfeeding
  • You have had major surgery or a serious injury within the 3 weeks before starting the study (except for a biopsy done as part of this study)
  • You are unable or unwilling to follow the study schedule and attend follow-up visits
  • You have any other significant health condition, abnormal test result, or finding that the doctors feel could make it unsafe for you to participate or could affect the study results

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 May 2003
Est. completion
1 July 2004

Primary endpoints

Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov