NCT00443196

Brief Summary

2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients for first-line treatment. 2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a third-line, refractory treatment setting (exclusive of anti-VEGF)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2011

First QC Date

June 14, 2006

Last Update Submit

March 9, 2018

Conditions

AdenocarcinomaOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Keywords

ChemosensitivityOvarian CancerChemotherapyFallopian AdenocarcinomaPeritoneal AdenocarcinomaPatients with pathological diagnoses of ovarian, fallopian and primary peritoneal adenocarcinomas.Patients with de novo malignancies and no previous chemotherapyPatients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols.

Outcome Measures

Primary Outcomes (1)

  • Complete Response, No Response

    9 months

Study Arms (1)

Experimental

EXPERIMENTAL
Procedure: MiCK Assay

Interventions

MiCK AssayPROCEDURE

Physician determined treatment

Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathological diagnoses of ovarian, fallopian and primary peritoneal adenocarcinomas.
  • Patients with de novo malignancies and no previous chemotherapy
  • Patients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols.
  • Patients of any age group.
  • Patients must have tumor which is accessible and agree to undergo biopsies, or drainage of effusions.
  • Patients for whom chemotherapy is a treatment option.
  • Explanations: We anticipate that newly diagnosed patients will be mostly used to evaluate the ability of the MiCK assay to predict the outcome of the chemotherapy (Objective #2.1) and to establish criteria correlating numerical response in the MiCK assay with probability of the clinically established complete remission. The patients with refractory malignancies will be mostly used to evaluate the ability of the MiCK assay to guide cancer chemotherapy (Objective #2.2). Patients will be seen and managed as outpatients or inpatients, depending on a clinical standard of the institution

You may not qualify if:

  • Patients with symptomatic/uncontrolled parenchimal brain metastasis and not accessible tumors.
  • Patients with meningeal metastasis.
  • Patients for whom chemotherapy clinically is not indicated.
  • Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive study medication and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study drugs, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeastern Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

AdenocarcinomaOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Study Officials

  • Cary Presant, MD

    Pierian Biosciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2006

First Posted

March 5, 2007

Study Start

March 1, 2006

Study Completion

September 1, 2010

Last Updated

March 12, 2018

Record last verified: 2011-03

Locations

US(1)