AzTrials
AzTrials

Ovarian CancerPhase 2NCT00083928

Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels

A Phase 2 study testing Å6 subcutaneous injection in people with Ovarian Cancer and Primary Peritoneal Carcinoma, run by Ångstrom Pharmaceuticals at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Primary Peritoneal Carcinoma
What is being tested?
Å6 subcutaneous injection
Type of treatment
Injection or infusion
How many people
60 participants
Where
24 sitesUnited States
Study dates
May 2004to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females ≥18 years of age
  • Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
  • Completion of first-line chemotherapy
  • Clinical remission as a result of chemotherapy
  • History of normal CA125 level after initial course of therapy
  • CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually >= 28 days apart, provided that:
Show all 13Show fewer
  • the 3rd sample is above the institution's ULN, and
  • the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
  • No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
  • ECOG Performance Status of 0 or 1
  • No clinically significantly abnormal clinical laboratory tests or concomitant illnesses
  • Ability and willingness to self-administer subcutaneous injections
  • Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial.

Who cannot join

  • Persistent adverse events due to agents administered more than 4 weeks earlier
  • More than 1 course of previous chemotherapy for the qualifying cancer
  • Disease requiring chemotherapy or radiotherapy
  • Ascites
  • Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80010

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85222

  • Chattanooga GYN Oncology

    Chattanooga, Tennessee, 37403

  • OSU College of Medicine

    Columbus, Ohio, 43210

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Gynecologic-Oncology Research and Development, LLC

    Greenville, South Carolina, 29601

  • Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • St. Vincent Gyn-Onc

    Indianapolis, Indiana, 46260

  • USC Keck School of Medicine Women's and Childrens Hospital

    Los Angeles, California, 90033

  • University of Louisville JG Brown Cancer Center

    Louisville, Kentucky, 40202

  • Hematology & Oncology Specialists

    New Orleans, Louisiana, 70115

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • University of California Irvine Medical Center

    Orange, California, 92668

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Carilion Gynecologic Oncology Associates

    Roanoke, Virginia, 24014

  • UC Davis Health System

    Sacramento, California, 95817

  • Medical College of Georgia Dept. of OB/GYN

    Saint Agusta, Georgia, 30912

  • Scripps Cancer Center

    San Diego, California, 92121

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46617

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy

The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.

Being tested
Å6 subcutaneous injection
Keywords
Asymptomatic, subcutaneous, CA125 Progression, Angstrom, Ångstrom, ovarian cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Å6 subcutaneous injectionDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionFeb 2006
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083928
Sponsor's protocol ID
Å6-003
Status last verified
Jan 2013
First submitted
3 Jun 2004
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Å6 subcutaneous injection in people with Ovarian Cancer and Primary Peritoneal Carcinoma, run by Ångstrom Pharmaceuticals at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in