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Trial record 1 of 3 for:    "Recepta" "hu3S193"
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Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT00617773
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Recepta Biopharma

Tracking Information
First Submitted Date  ICMJE February 15, 2008
First Posted Date  ICMJE February 18, 2008
Results First Submitted Date  ICMJE May 15, 2013
Results First Posted Date  ICMJE November 26, 2013
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Best Overall Response [ Time Frame: From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks). ]
Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125). Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
  • Tumor response as measured by RECIST criteria
  • Response as measured by CA-125 decline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
  • Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ]
    A listing of all adverse events is located in the Reported Adverse Event module.
  • Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ]
    Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.
  • Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. [ Time Frame: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1. ]
    Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
  • Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses [ Time Frame: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1. ]
    Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
  • Treatment safety during and for up to 30 days after completion of study treatment
  • Pharmacokinetics
  • Clinical benefit (objective response rate plus tumor stabilization)
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Survival rate at 12 months
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2013)
  • Clinical Benefit [ Time Frame: From start of study treatment until the end of Cycle 3 (24 weeks). ]
    The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown. Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population. The evaluation of target and non-target lesions is described at the Outcome Measure titled "Best Overall Response". CR: Complete Response; PR: Partial Response; SD: Stable Disease.
  • Progression Free Survival (PFS) [ Time Frame: From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks. ]
    Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.
  • Overall Survival [ Time Frame: From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks. ]
    Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.
  • 12-Month Survival Rate [ Time Frame: 12 months from the start of study treatment. ]
    Rate of patients alive 12 months after starting therapy with the investigational product.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title  ICMJE A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER
Brief Summary

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well Hu3S193 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria (Response Evaluation Criteria in Solid Tumors).

Secondary

  • To determine the safety of the study drug.
  • To determine the drug pharmacokinetics when administered in multiple weekly injections.

Exploratory analysis

  • Clinical Benefit (objective response rate + tumor stabilization).
  • Progression Free Survival (PFS).
  • Duration of Response.
  • Overall Survival.
  • 12-month survival rate.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE Biological: hu3S193
20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Study Arms  ICMJE Experimental: hu3S193
Intervention: Biological: hu3S193
Publications * Smaletz O, Diz MD, do Carmo CC, Sabbaga J, Cunha-Junior GF, Azevedo SJ, Maluf FC, Barrios CH, Costa RL, Fontana AG, Madrigal V, Wainstein AJ, Yeda FP, Alves VA, Moro AM, Blasbalg R, Scott AM, Hoffman EW. A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Gynecol Oncol. 2015 Aug;138(2):272-7. doi: 10.1016/j.ygyno.2015.05.023. Epub 2015 May 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2012)
31
Original Enrollment  ICMJE
 (submitted: February 15, 2008)
56
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Progressive disease
    • Disease must express Lewis-Y antigen documented by immunohistochemistry in archived or fresh primary or metastatic tumor biopsies
  • Measurable disease, including at least one measurable lesion, according to RECIST criteria or CA-125 (Cancer Antigen-125) > 2 times upper normal limit

    • Pleural effusion, ascites, bone metastases, and lesions located in previously irradiated areas are not considered measurable
  • Disease must be considered platinum-refractory or resistant, meeting any of the following criteria:

    • Platinum-refractory defined as progression during the initial platinum-based chemotherapy regimen or failure to achieve a complete response (e.g., stable disease or partial response) with evidence of progressive disease (by physical examination, radiological exams, or CA-125) during the initial platinum-based chemotherapy
    • Platinum-resistant defined as recurrence within six months of completion of the initial platinum-based regimen (primary platinum-resistance) or recurrence after six months of completion of the initial platinum-based regimen (still considered platinum-sensitive, but incurable by any approach, that will progress to a secondary platinum-resistance scenario) and failure to ≥ 1 re-induction with a platinum-based regimen (secondary platinum-resistance)
  • No high tumor burden, as assessed by the investigator
  • No rapidly progressing disease, as assessed by clinical evaluation
  • No known CNS (Central Nervous System) involvement by tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Karnofsky performance status > 70%
  • Life expectancy ≥ 12 weeks
  • ANC (absolute neutrophil count) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin ≤ 2.0 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if with liver metastases)
  • Creatinine ≤ 2.0 mg/dL
  • Prothrombin time < 1.3 times control
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • NYHA (New York Heart Association) class III or IV heart disease
  • Clinically significant arrhythmias by ECG
  • Myocardial infarction within the past 6 months
  • Any other serious illness, including any of the following:

    • Severe ascites
    • Severe active infections requiring antibiotics
    • Bleeding disorders
    • Chronic inflammatory bowel disease
    • Diseases that might interfere with the collection of accurate results from this study
  • Positive for human anti-human antibodies
  • Prior history of tumor (excluding adequately treated nonmelanoma skin cancer or carcinoma in situ of the uterine cervix)
  • Uncontrolled hypercalcemia (i.e., > 11.5 mg/dL)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from the toxic effects of any prior therapy
  • No concurrent systemic steroids or immunosuppressant agents
  • No more than 1 prior non-platinum-containing regimen for the treatment of platinum-resistant/refractory disease

    • Patients who receive 2 or more different non-platinum-containing chemotherapy regimens for platinum-resistant/refractory disease are not eligible
  • More than 4 weeks since prior and no other concurrent chemotherapy, radiotherapy, radiopharmaceuticals (e.g., ^32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy, or surgery
  • More than12 weeks since prior investigational agent
  • No prior treatment with a murine or humanized antibody and/or antibody fragment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617773
Other Study ID Numbers  ICMJE RCPOv01-06
RCP-Ov-01.06 ( Other Identifier: Recepta Biopharma )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Recepta Biopharma
Study Sponsor  ICMJE Recepta Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Oren Smaletz, MD Recepta Biopharma
PRS Account Recepta Biopharma
Verification Date November 2013

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