Solid TumorPhase 1NCT01359696
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
A Phase 1 study testing GDC-0425 and gemcitabine in people with Solid Tumor, run by Genentech, Inc. at 3 sites in 2 countries.
Trial summary
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GDC-0425 and gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Jul 2011to 29 May 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
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Signed Informed Consent Form
- Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
- Adequate hematologic and end-organ (liver and kidney) function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement by the patient that the patient and/or partner will use an effective form of contraception
- Patients enrolled in certain phases must be willing to provide fresh and/or archival tumor samples
Who cannot join
- History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment
- Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine
- Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment
- Radiotherapy within 2 weeks prior to first dose of study drug treatment
- More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
- History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
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- History of receiving radiation to more than 25% of bone marrow-bearing areas
- Acute drug-related toxicities from previous therapies have not resolved prior to study entry, except for alopecia and mild neuropathy
- Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer
- Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility
- Uncontrolled ascites, due to diseases other than cancer
- Inability or unwillingness to swallow pills/capsules
- History of malabsorption or other condition that would interfere with drug absorption
- Any history of active stomach and/or intestine bleeding within the 6 months prior to screening
- Known HIV infection
- Pregnancy, lactation, or breastfeeding
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- Inability to comply with study and follow up procedures
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Karmanos Cancer Institute..
Detroit, Michigan, 48201
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
France1 site
Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo
Villejuif, 94805
About this study
Official title: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
- Conditions
- Solid Tumor
- Being tested
- GDC-0425, gemcitabine
- Keywords
- solid cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0425Drug
Oral escalating dose
gemcitabineDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0425; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all adverse events graded according to NCI CTCAE, v4.0
Measured: Up to 1 year
Incidence of dose limiting toxicities (DLTs)
Measured: Up to 35 days
Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
Measured: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: exposure
Measured: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: half-life
Measured: Up to 12 months or early study discontinuation
Severity of all adverse events graded according to NCI CTCAE, v4.0
Measured: Up to 1 year
Secondary outcomes (1)
Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease
Measured: Up to 12 months 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 posted25 May 2011 (estimated)
- Study start11 Jul 2011
- Primary completion29 May 2014
- Study completion29 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia Portera, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359696
- Sponsor's protocol ID
- DPM4957g
- Other IDs
- GO00767
- Status last verified
- Apr 2017
- First submitted
- 23 May 2011
- Last updated
- 12 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT01359696
- Acronym / sponsor ID
- DPM4957g
- Conditions
- Solid Tumor
- Keywords
- solid cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2011 (actual)
- Primary completion
- 29 May 2014 (actual)
- Study completion
- 29 May 2014 (actual)
- First posted
- 25 May 2011 (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 I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0425, Drug: gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Signed Informed Consent Form
- Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
- Adequate hematologic and end-organ (liver and kidney) function
Key exclusion criteria (18 listed)
- History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment
- Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine
- Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment
- Radiotherapy within 2 weeks prior to first dose of study drug treatment
- More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
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-0425Oral escalating dose | Drug | A |
| gemcitabineIntravenous repeating dose | Drug | A |
Primary outcome
Incidence of all adverse events graded according to NCI CTCAE, v4.0
Time frame: Up to 1 year
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 35 days
Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
Time frame: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: exposure
Time frame: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: half-life
Time frame: Up to 12 months or early study discontinuation
Severity of all adverse events graded according to NCI CTCAE, v4.0
Time frame: Up to 1 year
1 secondary outcome
Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease
Time frame: Up to 12 months 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 12 Apr 2017.
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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.
Chia Portera, M.D., Ph.D. study director
Genentech, Inc.
3 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-0425 and gemcitabine in people with Solid Tumor, run by Genentech, Inc. at 3 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 7 inclusion and 18 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. 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 of all adverse events graded according to NCI CTCAE, v4.0 (time frame: Up to 1 year). The study lists 6 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 12 Apr 2017.