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Renal Cell CarcinomaPhase 2NCT01442090

Study of GDC-0980 Versus Everolimus in Participants With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted Therapy

A Phase 2 study testing Everolimus and GDC-0980 in people with Renal Cell Carcinoma, run by Genentech, Inc. at 22 sites in 5 countries.

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

Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Everolimus and GDC-0980
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
22 sitesin 5 countries
Study dates
Oct 2011to Jul 2015
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented, incurable metastatic renal cell carcinoma with clear-cell component that progressed on or within 6 months of stopping VEGF-targeted therapy
  • Disease that is measurable per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
  • Karnofsky performance status of greater than or equal to (>=) 70 percent (%)
  • Adequate hematologic and end organ function
  • For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use two effective forms of contraception and to continue its use for the duration of the study

Who cannot join

  • Any anti-cancer therapy, including chemotherapy, biologic or other targeted therapy, herbal therapy, hormonal therapy, or radiotherapy, within 5 half-lives (for systemic agents) or 2 weeks, whichever is shorter, prior to Day 1. Certain forms of radiation therapy may be considered for pain palliation if participants are deriving benefit
  • Previously established diagnosis of pulmonary fibrosis of any cause
  • New York Heart Association (NYHA) Class II or greater congestive heart failure
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Presence of positive test results for hepatitis B (hepatitis B [HB] surface antigen [HBsAg] and/or total HB core antibody [anti-HB-c; both tests are required]) or hepatitis C
  • Known human immunodeficiency virus (HIV) infection
Show all 11Show fewer
  • Pregnancy, lactation, or breastfeeding
  • 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
  • Leptomeningeal disease as a manifestation of cancer
  • History of other malignancies less than equal to <= 5 years of Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Need for current chronic corticosteroid therapy (>= 10 milligrams [mg] of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids for greater than [>] 7 days) or use of other immunosuppressant

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

United States8 sites

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Fort Myers, Florida, 33908

  • Study site

    Las Vegas, Nevada, 89148

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10065

  • Study site

    St. Petersburg, Florida, 33705

Other trials in United States

United Kingdom5 sites

  • Study site

    Leeds, LS9 7TF

  • Study site

    London, EC1A 7BE

  • Study site

    London, SW3 6JJ

  • Study site

    Manchester, M20 4BX

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

France3 sites

  • Study site

    Bordeaux, 33075

  • Study site

    Paris, 75908

  • Study site

    Villejuif, 94800

Other trials in France

Germany3 sites

  • Study site

    Berlin, 10117

  • Study site

    Hanover, 30625

  • Study site

    München, 81377

Other trials in Germany

Spain3 sites

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Madrid, Madrid, 28041

Other trials in Spain

About this study

Official title: A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy

Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.

Being tested
Everolimus, GDC-0980
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • EverolimusDrug

    Everolimus will be administered orally at a 10 mg daily dose.

  • GDC-0980Drug

    GDC-0980 will be administered orally at a 40 mg daily dose.

Study groups in NCT01442090
Study groupRoleWhat they receive
EverolimusActive comparatorParticipants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: Everolimus
GDC-0980ExperimentalParticipants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Receives: Drug: GDC-0980

What is being measured

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

  1. DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1

    Measured: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)

Secondary outcomes (8)

  1. Maximum plasma concentration (Cmax) of GDC-0980

    Measured: pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)

  2. Cmax of everolimus

    Measured: pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n

  3. Minimum plasma concentration (Cmin) of GDC-0980

    Measured: pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1

  4. Cmin of everolimus

    Measured: pre-dose on Week 1 Day 1 and Week 9 Day 1

  5. Number of participants with adverse events

    Measured: up to 30 days after end of treatment (approximately up to 23 months)

  6. Number of participants with objective tumor response as assessed by the investigator using RECIST v1.1

    Measured: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)

  7. Duration of objective tumour response as assessed by the investigator using RECIST v1.1

    Measured: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)

  8. Duration of overall survival (OS)

    Measured: Baseline until death (up to approximately 45 months)

Timeline

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

  1. First posted28 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2013
  4. Study completionJul 2015

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
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442090
Sponsor's protocol ID
PIM4973g
Other IDs
GO00885, 2011-000493-56
Status last verified
May 2016
First submitted
26 Sep 2011
Last updated
10 Aug 2016
Results posted
No

Publications

  • Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ. Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7.

    PubMed 26951309

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus and GDC-0980 in people with Renal Cell Carcinoma, run by Genentech, Inc. at 22 sites in 5 countries.

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 5 inclusion and 11 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 10 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 22 sites in United States, United Kingdom, France, Germany, Spain. 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?

DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1 (time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)). 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 NCT01442090, which also lists 1 linked publication.

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 10 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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