NCT01332604
Completed
Phase 1
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
ConditionsSolid Cancers
Overview
- Phase
- Phase 1
- Intervention
- GDC-0980
- Conditions
- Solid Cancers
- Sponsor
- Genentech, Inc.
- Enrollment
- 41
- Primary Endpoint
- Nature of adverse events graded according to NCI CTCAE, v4.0
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
- •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
Arms & Interventions
A
Intervention: GDC-0980
A
Intervention: capecitabine
B
Intervention: GDC-0980
B
Intervention: bevacizumab
B
Intervention: mFOLFOX6
Outcomes
Primary Outcomes
Nature of adverse events graded according to NCI CTCAE, v4.0
Time Frame: Up to 30 days after last dose of study treatment
Severity of adverse events
Time Frame: Up to 30 days after last dose of study treatment
Incidence of adverse events
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
Incidence of dose limiting toxicities (DLTs)
Time Frame: Up to Day 21 for Arm A and up to Day 28 for Arm B
Secondary Outcomes
- Total exposure from Time 0 to the last measurable concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Maximum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Minimum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
- Time to maximum observed plasma concentration(Up to Day 2 for Arm B and up to Day 9 for Arm A)
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