Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00770536 · ClinicalTrials.gov registry record · Phase 1

AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR

A Phase 1 study of Cancer and Ovarian Cancer, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
103
Enrollment target
16
Study locations

NCT00770536 is a Phase 1 study of Cancer and Ovarian Cancer that has completed, run by Amgen. The registered enrollment target is 103 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 16 study locations across 11 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00770536, a Phase 1 study of Cancer and Ovarian Cancer, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
103 participants
Enrollment target
16
Study locations

Study Summary

This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion. It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.

Conditions Studied

Cancer Ovarian Cancer Solid Tumors Fallopian Tube Cancer Carcinoma Oncology Tumors Metastases Gynecological Malignancies

Interventions

  • DRUG A1: AMG 386 10 mg/kg + Liposomal doxorubicin
  • DRUG A3: AMG 386 15mg/kg + Liposomal doxorubicin
  • DRUG B1: AMG 386 10 mg/kg + Topotecan
  • DRUG B3: AMG 386 15mg/kg + Topotecan

Study Locations (16)

Other

  • Research Site - Leuven
  • Research Site - Liège
  • Research Site - Liège
  • Research Site - Wilrijk

Florida

  • Research Site - Orlando
  • Research Site - Tampa

Victoria

  • Research Site - Footscray
  • Research Site - Parkville

Arizona

  • Research Site - Tucson

California

  • Research Site - Sacramento

Minnesota

  • Research Site - Saint Louis Park

North Carolina

  • Research Site - Winston-Salem

North Dakota

  • Research Site - Bismarck

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2009-01
Est. Completion 2015-06
Phase Phase 1

Sponsor

Amgen

558 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00770536

The ClinicalTrials.gov registry entry for NCT00770536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which A1: AMG 386 10 mg/kg + Liposomal doxorubicin is the first listed.

NCT00770536 reports 16 study locations spanning 11 distinct geographic areas - top geographies include Other, Florida, Victoria.

Frequently Asked Questions

What is clinical trial NCT00770536 about?

NCT00770536 is a clinical study titled "AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR". This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated ...

What is the current status of trial NCT00770536?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2009-01. Estimated completion is 2015-06.

What conditions does trial NCT00770536 study?

This clinical trial studies the following conditions: Cancer, Ovarian Cancer, Solid Tumors, Fallopian Tube Cancer, Carcinoma.

What interventions are being tested in trial NCT00770536?

The interventions under investigation include: A1: AMG 386 10 mg/kg + Liposomal doxorubicin (DRUG), A3: AMG 386 15mg/kg + Liposomal doxorubicin (DRUG), B1: AMG 386 10 mg/kg + Topotecan (DRUG), B3: AMG 386 15mg/kg + Topotecan (DRUG).

Who is sponsoring clinical trial NCT00770536?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00770536 being conducted?

This trial has 16 study locations across Arizona, California, Florida, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Cancer

All registered trials for this condition

Ovarian Cancer

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.