Non-Squamous Non-Small Cell Lung Cancer, Solid CancersPhase 1NCT00975182
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
A Phase 1 study testing GDC-0941 and erlotinib HCl in people with Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers, run by Genentech, Inc. at 4 sites in 2 countries.
Trial summary
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
- What is being tested?
- GDC-0941 and erlotinib HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2009to Sep 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
- Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
- Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
- Adequate organ function as assessed by laboratory tests
- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
- Agreement to use an effective form of contraception for the duration of the study
Who cannot join
- Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
- Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
- History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
- Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
Show all 11Show fewer
- Clinically significant history of liver disease
- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
- Active autoimmune disease and/or need for corticosteroid therapy
- Known brain metastases that are untreated, symptomatic, or require therapy
- Pregnancy, lactation, or breastfeeding
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Study site
Aurora, Colorado, 80045
Study site
New Brunswick, New Jersey, 08903
Netherlands2 sites
Study site
Amsterdam, 1066 EC
Study site
Utrecht, 3508 GA
About this study
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
- Being tested
- GDC-0941, erlotinib HCl
- Keywords
- PI3K, NSCLC, Tarceva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0941Drug
Oral repeating dose
erlotinib HClDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0941; Drug: erlotinib HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
Tumor response
Measured: Assessed at periodic intervals
Secondary outcomes (1)
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)
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.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung Cancer, Solid CancersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975182
- Sponsor's protocol ID
- GDC4626g
- Other IDs
- GO01301
- Status last verified
- Nov 2016
- First submitted
- 8 Sep 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00975182
- Acronym / sponsor ID
- GDC4626g
- Keywords
- PI3K, NSCLC, Tarceva
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0941, Drug: erlotinib HCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
- Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
- Adequate organ function as assessed by laboratory tests
- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
- Agreement to use an effective form of contraception for the duration of the study
Key exclusion criteria (11 listed)
- Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
- Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
- History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
- Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
- History of clinically significant cardiac or pulmonary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0941Oral repeating dose | Drug | A |
| erlotinib HClOral repeating dose | Drug | A |
Primary outcome
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Tumor response
Time frame: Assessed at periodic intervals
1 secondary outcome
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)
Time frame: Through study completion or early study discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 1
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0941 and erlotinib HCl in people with Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers, run by Genentech, Inc. at 4 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 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 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 4 sites in United States, Netherlands. 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?
Incidence, nature, and severity of adverse events (time frame: Through study completion or early study discontinuation). 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?
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.