AzTrials
AzTrials

Non-Hodgkin's Lymphoma, Solid CancersPhase 1NCT00876122

A Study of GDC-0941 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

A Phase 1 study testing GDC-0941 in people with Non-Hodgkin's Lymphoma, Solid Cancers, run by Genentech, Inc. at 1 site in United Kingdom.

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

This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD. 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-0941
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2008to Jul 2012
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 or cytologically documented, incurable, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or has failed to respond to at least one prior regimen
  • Multiple myeloma (MM) patients (only in Stage 2): documented pathologic diagnosis of MM that has relapsed or that has failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
  • Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) or per International Working Group (IWG) response criteria for Non-Hodgkin's lymphoma (NHL) patients
  • Life expectancy of >= 12 weeks
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study
  • For patients participating in Stage 1 after an adequate exposure has been predicted or observed on the basis of PK analysis and for approximately 12 patients participating in Stage 2 (excluding patients with MM): A biopsy-accessible lesion from which tissue can be obtained safely with CT guidance or direct visualization and agreement from the patient to undergo sequential (pre-treatment and post-treatment) biopsies.
  • For patients participating in Stage 2 DCE-MRI and MRS imaging: Patients will have at least one metastatic liver lesion measuring >= 5 cm in one dimension or one tumor lesion elsewhere measuring >= 2 cm in one dimension (lung and mediastinum lesions do not qualify) on the basis of CT scans

Who cannot join

  • Leptomeningeal disease as the only manifestation of the current malignancy
  • History of Type 1 or 2 diabetes mellitus requiring regular medication
  • Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytics
  • Inability or unwillingness to swallow pills
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Known untreated CNS malignancies or treated brain metastases that are not radiographically stable for >= 3 months
Show all 31Show fewer
  • Congenital long QT syndrome or QTc > 500 msec, as determined by at least two of the three baseline ECG measurements
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
  • Active infection requiring intravenous (IV) antibiotics
  • Patients requiring any daily supplemental oxygen
  • DLco, 50% predicted value corrected for AV and Hgb prior to initiation of study treatment
  • Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN) or hypercalcemia above the ULN for the institution despite adequate electrolyte supplementation or management
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus (HIV) infection
  • Any other diseases, active or uncontrolled 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 or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
  • Significant traumatic injury within 3 weeks before Day 1
  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) at any time or autologous HSCT within 12 weeks of study entry
  • Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment (exceptions are kinase inhibitors that are approved by the local regulatory authorities, which may be used within 2 weeks prior to initiation of study treatment, provided that any drug-related toxicity has completely resolved and after approval by the Medical Monitor has been granted)
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
  • Need for chronic corticosteroid therapy
  • Treatment with an investigational agent within 4 weeks prior to initiation of study treatment
  • Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
  • Pregnancy or lactation
  • Inability to comply with study and follow-up procedures
  • For patients eligible to participate in Stage 2 DCE-MRI and MRS assessments, any contraindication to MRI examination, including the following:
  • Imbedded metallic material/devices (metal implants or large tattoos in the field of view)
  • Severe claustrophobia
  • Physical characteristics (weight or size) that exceed the capabilities of the MRI scanner
  • Known allergy or hypersensitivity reactions to gadolinium, verse

Trial locations and contacts

1 site in 1 country.

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 of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD. This study will include patients with locally advanced or metastatic solid tumors, NHL, or multiple myeloma (MM) (expansion stage only) for which standard therapy either does not exist or has proven ineffective or intolerable.

Being tested
GDC-0941
Keywords
NHL, Metastatic Solid Tumors, PI3K Inhibitors, PI3K
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • GDC-0941Drug

    Escalating oral dose

Study groups in NCT00876122
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: GDC-0941

What is being measured

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

  1. Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0941

    Measured: Through study completion or early study discontinuation

  2. Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0941

    Measured: Through study completion or early study discontinuation

  3. Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0941

    Measured: Through study completion or early study discontinuation

  4. PK parameters after single and multiple doses of GDC-0941

    Measured: Through study completion or early study discontinuation

Secondary outcomes (2)

  1. Positron emission tomography (PET) response for patients with detectable FDG tumor uptake at baseline

    Measured: Through study completion or early study discontinuation

  2. Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST

    Measured: Through study completion or early study discontinuation

Timeline

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

  1. First posted6 Apr 2009 (estimated)
  2. Study startMar 2008
  3. Primary completionJun 2012
  4. Study completionJul 2012

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876122
Sponsor's protocol ID
GDC4254g
Other IDs
GO01299
Status last verified
Nov 2016
First submitted
13 Mar 2009
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-0941 in people with Non-Hodgkin's Lymphoma, Solid Cancers, run by Genentech, Inc. at 1 site in United Kingdom.

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 7 inclusion and 31 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 1 site in 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 by NCI CTCAE grade and associated dose of GDC-0941 (time frame: Through study completion or early study discontinuation). 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 NCT00876122.

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.

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