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A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

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ClinicalTrials.gov Identifier: NCT01059643
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):

January 11, 2010
February 1, 2010
September 27, 2017
December 4, 2017
December 4, 2017
April 2011
December 2012   (Final data collection date for primary outcome measure)
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline until progressive disease up to 36 weeks post-baseline ]
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Percentage of patients with a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline assessment until first evidence of progressive disease ]
Complete list of historical versions of study NCT01059643 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment ]
    PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
  • Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [ Time Frame: Baseline until progressive disease up to 36 weeks post-baseline ]
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
  • Tumor Marker Values as Relevant to Specific Tumor Types at Baseline [ Time Frame: Baseline ]
    The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
  • Change in Tumor Size at Smallest Size (Best Response) [ Time Frame: Baseline until cycle with maximum change from baseline up to 36 weeks ]
    The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
  • Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 [ Time Frame: Day 3 of Cycle 1 (21-day cycle) ]
    Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).
  • Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 [ Time Frame: Day 1 and Day 3 of Cycle 1 (21-day cycle) ]
    Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.
  • Progression free survival [ Time Frame: Date of enrollment to the first date of progressive disease or death due to any cause ]
  • Percentage of patients who achieved a best response of CR, PR or Stable Disease (SD) [ Time Frame: Baseline assessment until first evidence of progressive disease ]
  • Change in tumor marker values as relevant to specific tumor types [ Time Frame: Baseline assesment until first evidence of progressive disease ]
  • Maximum plasma concentration (Cmax) of LY2523355 and metabolite LSN2546307 [ Time Frame: Baseline to Day 1 of Cycle 2 ]
  • Change in tumor size at best response [ Time Frame: Baseline assessment until cycle with maximum change from baseline ]
  • Intracycle accumulation ratio of LY2523355 [ Time Frame: Day 1 to Day 9 of Cycle 1 ]
Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up [ Time Frame: End of study treatment up to 30-days post-study treatment discontinuation ]
Not Provided
 
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
A Phase 2 Indication Identification Study of LY2523355 in Patients With Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Non Small Cell Lung Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Cancer of Head and Neck
  • Drug: LY2523355
    Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.
  • Drug: pegfilgrastim
    6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.
Experimental: LY2523355
Interventions:
  • Drug: LY2523355
  • Drug: pegfilgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
  • Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Are willing to follow study procedures for the duration of the study
  • Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment

Exclusion Criteria:

  • Have a serious preexisting medical condition that would preclude participation in the study
  • Are pregnant or lactating
  • Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
  • Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
  • Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
  • Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
  • Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
  • Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01059643
12848
I1Y-MC-JFBF ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1- 317-615-4559 Mon - Fri 9 AM to 5 PM (Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP