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Non-Hodgkin's Lymphoma, Solid CancersPhase 1NCT00854152

A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

A Phase 1 study testing GDC-0980 in people with Non-Hodgkin's Lymphoma, Solid Cancers, run by Genentech, Inc. at 5 sites in 2 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

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma, Solid Cancers
What is being tested?
GDC-0980
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
5 sitesin 2 countries
Study dates
Mar 2009to Nov 2014
Phase
Phase 1
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 documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
  • ECOG performance status of 0 or 1 at screening
  • Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
  • Life expectancy >=12 weeks
  • Adequate hematologic and organ function within 14 days before initiation of GDC-0980
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study

Who cannot join

  • Leptomeningeal disease as the only manifestation of the current malignancy
  • History of Type 1 or 2 diabetes mellitus requiring regular medication
  • Grade >= 2 hypercholesterolemia or hypertriglyceridemia
  • Ejection fraction that is <50% or below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
  • DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume prior to initiation of GDC-0980
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
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  • Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Active infection requiring IV antibiotics
  • Requirement for any daily supplemental oxygen
  • Uncontrolled hypomagnesemia
  • Hypercalcemia requiring continued use of bisphosphonate therapy
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Uncontrolled ascites requiring frequent paracentesis
  • Known HIV infection
  • Any other diseases, active or controlled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug
  • Significant traumatic injury within 4 weeks of Day 1
  • Major surgical procedure within 4 weeks prior to initiation of GDC-0980
  • For all patients participating in Stage 2: Prior treatment with any PI3K inhibitor, mTOR inhibitor or dual PI3K/mTOR inhibitor. For HNSCC patients, this restriction applies only to any PI3K inhibitor, mTOR inhibitor, or dual PI3K/mTOR inhibitor used in the palliative setting.
  • Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980
  • Need for chronic corticosteroid therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
  • Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980
  • Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy
  • Pregnancy or lactation
  • For patients participating in DCE-MRI assessments, any contraindication to MRI examination
  • For patients with advanced solid tumors or NHL participating in the PPI-effect assessment: Known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10065

Other trials in United States

United Kingdom1 site

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: An Open-label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

Being tested
GDC-0980
Keywords
NHL, Tumors, Carcinogenic Tumors
Medical subject headings
Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

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

  • GDC-0980Drug

    Escalating repeating dose

Study groups in NCT00854152
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: GDC-0980

What is being measured

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

  1. Occurrence of adverse events

    Measured: Length of study

  2. Occurrence of dose-limiting toxicities

    Measured: Length of study

  3. PK parameters after doses of GDC-0980

    Measured: Length of study

  4. Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980

    Measured: Length of study

Secondary outcomes (1)

  1. Best overall response, duration of objective response, and progression-free survival for patients with measurable disease

    Measured: Length of study

Timeline

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

  1. First posted3 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2014
  4. Study completionNov 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854152
Sponsor's protocol ID
PIM4604g
Other IDs
MP00880
Status last verified
Nov 2016
First submitted
27 Feb 2009
Last updated
2 Nov 2016
Results posted
No

Publications

  • Moein A, Jin JY, Wright MR, Alicke B, Wong H. Retrospective Assessment of Translational Pharmacokinetic-Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor. Drugs R D. 2024 Jun;24(2):155-167. doi: 10.1007/s40268-024-00459-5. Epub 2024 May 3.

    PubMed 38700808

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-0980 in people with Non-Hodgkin's Lymphoma, Solid Cancers, run by Genentech, Inc. at 5 sites in 2 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 6 inclusion and 27 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Occurrence of adverse events (time frame: Length of study). The study lists 4 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 NCT00854152, 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 2 Nov 2016.

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