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Endometrial CarcinomaPhase 2NCT01455493

A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

A Phase 2 study testing GDC-0980 in people with Endometrial Carcinoma, run by Genentech, Inc. at 28 sites in United States.

Completed

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

Official record
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Trial summary

This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Carcinoma
What is being tested?
GDC-0980
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
28 sitesUnited States
Study dates
Dec 2011to Jan 2014
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

  • Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments
  • Histologic confirmation of the original primary tumor is required
  • Histologic or cytologic confirmation of the recurrent/progressive disease is desired
  • Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma
  • Disease that is measurable per RECIST v1.1
  • No active infection requiring antibiotics
Show all 9Show fewer
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment
  • Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment
  • Adequate hematologic and end organ function

Who cannot join

  • Type I diabetes or Type II diabetes requiring insulin
  • Prior use of mTOR/PI3K inhibitor
  • Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living
  • Previous diagnosis of pulmonary fibrosis of any cause
  • History of myocardial infarction or unstable angina within 6 months prior to first study treatment
  • Congestive heart failure
Show all 19Show fewer
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease, including cirrhosis and current alcohol abuse
  • Presence of positive test results for hepatitis B or hepatitis C
  • Known HIV infection
  • Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
  • Need for current chronic corticosteroid therapy
  • Pregnancy, lactation, or breastfeeding
  • Current severe, uncontrolled systemic disease
  • Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment
  • Uncontrolled hypercalcemia
  • Leptomeningeal disease as a manifestation of cancer
  • Known untreated or active brain metastases
  • Grade >=2 hypercholesterolemia or hypertriglyceridemia

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Study site

    Abington, Pennsylvania, 19001

  • Study site

    Baltimore, Maryland, 21231

  • Study site

    Boca Raton, Florida, 33487

  • Study site

    Boston, Massachusetts, 02115-6084

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Denver, Colorado, 80220

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Hinsdale, Illinois, 60521

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    New Haven, Connecticut, 06511

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10017

  • Study site

    Newport Beach, California, 92663

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32804

  • Study site

    Palo Alto, California, 94305

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    San Francisco, California, 94115

  • Study site

    Scarborough, Maine, 04074

  • Study site

    Seattle, Washington, 98195

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma

This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.

Being tested
GDC-0980
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • GDC-0980Drug

    Oral daily dose

Study groups in NCT01455493
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: GDC-0980

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response as assessed by the investigator using RECIST v1.1

    Measured: up to approximately 23 months

  2. Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study

    Measured: at 6 months

Secondary outcomes (5)

  1. Overall survival (OS), defined as the time from treatment initiation until death from any cause

    Measured: up to approximately 36 months

  2. Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1

    Measured: up to approximately 23 months

  3. Incidence of adverse events

    Measured: up to approximately 23 months

  4. Nature of adverse events

    Measured: up to approximately 23 months

  5. Severity of adverse events

    Measured: up to approximately 23 months

Timeline

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

  1. First posted20 Oct 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2013
  4. Study completionJan 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455493
Sponsor's protocol ID
PIM4972g
Status last verified
Aug 2016
First submitted
18 Oct 2011
Last updated
11 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GDC-0980 in people with Endometrial Carcinoma, run by Genentech, Inc. at 28 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 9 inclusion and 19 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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.

What does the primary outcome measure?

Objective tumor response as assessed by the investigator using RECIST v1.1 (time frame: up to approximately 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01455493.

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 11 Aug 2016.

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