Solid CancersPhase 1NCT01332604
GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
A Phase 1 study testing GDC-0980, bevacizumab and capecitabine in people with 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 designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- GDC-0980, bevacizumab and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2011to Jun 2015
- 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 locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist
- Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)
- Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)
Who cannot join
- Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to >= 25% of bone marrow-bearing areas
- Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known untreated or active central nervous system (CNS) metastases
- Pregnancy, lactation, or breastfeeding
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- For Arm B:
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
- History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment
- Significant vascular disease within 6 months prior to the first dose of study treatment
- History of hemoptysis within 1 month prior to the first dose of study treatment
- Patients with one or more pulmonary tumor masses with evidence of cavitation
- Evidence of bleeding diathesis or significant coagulopathy
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment
- Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding
- Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- The presence of an ulcerating breast cancer tumor will not render a patient ineligible
- Proteinuria
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Study site
Aurora, Colorado, 80045
Study site
Los Angeles, California, 90095
Study site
Rochester, Minnesota, 55905
About this study
Official title: A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.
- Conditions
- Solid Cancers
- Being tested
- GDC-0980, bevacizumab, capecitabine, mFOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0980Drug
Oral escalating dose
bevacizumabDrug
Intravenous repeating dose
capecitabineDrug
Oral repeating dose
mFOLFOX6Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0980; Drug: capecitabine |
| B | Experimental | Not described Receives: Drug: GDC-0980; Drug: bevacizumab; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 30 days after last dose of study treatment
Incidence of dose limiting toxicities (DLTs)
Measured: Up to Day 21 for Arm A and up to Day 28 for Arm B
Nature of adverse events graded according to NCI CTCAE, v4.0
Measured: Up to 30 days after last dose of study treatment
Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0
Measured: Up to 28 days
Severity of adverse events
Measured: Up to 30 days after last dose of study treatment
Secondary outcomes (4)
Total exposure from Time 0 to the last measurable concentration
Measured: Up to Day 2 for Arm B and up to Day 9 for Arm A
Maximum observed plasma concentration
Measured: Up to Day 2 for Arm B and up to Day 9 for Arm A
Minimum observed plasma concentration
Measured: Up to Day 2 for Arm B and up to Day 9 for Arm A
Time to maximum observed plasma concentration
Measured: Up to Day 2 for Arm B and up to Day 9 for Arm A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT01332604
- Sponsor's protocol ID
- PIM4945g
- Other IDs
- GO00883
- Status last verified
- Nov 2016
- First submitted
- 31 Mar 2011
- 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-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01332604
- Acronym / sponsor ID
- PIM4945g
- Conditions
- Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Apr 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 Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0980, Drug: capecitabine |
| B | Experimental | Drug: GDC-0980, Drug: bevacizumab, Drug: mFOLFOX6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist
- Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)
- Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)
Key exclusion criteria (22 listed)
- Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to >= 25% of bone marrow-bearing areas
- Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Bisphosphonate therapy for symptomatic hypercalcemia
- Known untreated or active central nervous system (CNS) metastases
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-0980Oral escalating dose | Drug | A, B |
| bevacizumabIntravenous repeating dose | Drug | B |
| capecitabineOral repeating dose | Drug | A |
| mFOLFOX6Intravenous repeating dose | Drug | B |
Primary outcome
Incidence of adverse events
Time frame: Up to 30 days after last dose of study treatment
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to Day 21 for Arm A and up to Day 28 for Arm B
Nature of adverse events graded according to NCI CTCAE, v4.0
Time frame: Up to 30 days after last dose of study treatment
Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0
Time frame: Up to 28 days
Severity of adverse events
Time frame: Up to 30 days after last dose of study treatment
4 secondary outcomes
Total exposure from Time 0 to the last measurable concentration
Time frame: Up to Day 2 for Arm B and up to Day 9 for Arm A
Maximum observed plasma concentration
Time frame: Up to Day 2 for Arm B and up to Day 9 for Arm A
Minimum observed plasma concentration
Time frame: Up to Day 2 for Arm B and up to Day 9 for Arm A
Time to maximum observed plasma concentration
Time frame: Up to Day 2 for Arm B and up to Day 9 for Arm A
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.
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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.
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-0980, bevacizumab and capecitabine in people with 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 3 inclusion and 22 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, 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 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 adverse events (time frame: Up to 30 days after last dose of study treatment). The study lists 5 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.