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OpenTrials
Completed

NCT Number: NCT00428610

A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brescia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • At least 18 years old
  • Have received at least one but no more than 2 systemic treatment regimens containing platinum (does not include regimens received before surgery for this cancer)
  • Have platinum-resistant disease

Exclusion criteria

  • Have received more than 2 systemic treatment regimens for platinum-resistant disease
  • Serious pre-existing medical conditions
  • Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other prothrombotic conditions

Treatment and study plan

LY573636-sodium

Drug

LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.

Other names: tasisulam, LY573636

Primary outcomes

  1. Percentage of Participants With Complete Response and Partial Response (Objective Response Rate)

    Time frame: Baseline to measured progressive disease up to 12.68 months

    Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

Secondary outcomes

  1. Progression Free Survival

    Time frame: Baseline to measured progressive disease or death due to any cause up to 21.26 months

    Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

  2. Percentage of Participants With Complete Response, Partial Response, and Stable Disease (Clinical Benefit Rate)

    Time frame: Baseline to measured progressive disease up to 21.26 months

    Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated multiplied by 100.

  3. Pharmacokinetics: Maximum Concentration (Cmax) of LY573636

    Time frame: Predose up to 2 hours postdose in Cycles 1 and 2

  4. Overall Survival

    Time frame: First treatment to death due to any cause up to 42.91 months

    Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact.

  5. Duration of Response

    Time frame: Time of response to time of measured progressive disease up to 12.68 months

    The duration of response (complete response [CR] or partial response [PR]) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.

  6. Duration of Stable Disease

    Time frame: Time from documented SD or better to first date of progressive disease or death due to any cause up to 21.26 months

    Duration of stable disease is defined from date of documented stable disease (SD) or better to first date of progressive disease or death from any cause (assessed every cycle during study therapy, or every 2 months during post-therapy until disease progression or death). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

  7. Number of Participants With Adverse Events (Safety)

    Time frame: First treatment dose up to 43.91 months

    Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.

Other outcomes

  1. Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment

    Time frame: Study treatment discontinuation up to 30 days post study treatment discontinuation

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of LY573636-Sodium as Treatment for Patients With Platinum-Resistant Ovarian Cancer

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Jan 30, 2007
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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