Clinical trial NCT01301716: A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
* Adequate hematologic and end organ function
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
* Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)

Exclusion Criteria:

* Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
* Uncontrolled hypomagnesemia or hypokalemia
* History of Grade \>= 3 fasting hyperglycemia
* Any condition requiring full-dose anticoagulants
* Known HIV infection
* Known untreated or active central nervous system (CNS) metastases
* Pregnancy, lactation, or breastfeeding
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
* For Arm B: Conditions that preclude the use of bevacizumab
* For Arm C: Conditions that preclude the use of pemetrexed or cisplatin

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
measure: Nature of adverse events
timeFrame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
measure: Nature of dose limiting toxicities (DLTs)
timeFrame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
measure: Severity of adverse events
timeFrame: Up to 30 days after last dose of study treatment
Secondary outcomes:
measure: Total exposure
timeFrame: Up to 32 months or early study discontinuation
measure: Maximum plasma concentration
timeFrame: Up to 32 months or early study discontinuation
measure: Time to maximum observed plasma concentration
timeFrame: Up to 32 months or early study discontinuation
measure: Plasma half-life
timeFrame: Up to 32 months or early study discontinuation
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Madrid
country: Spain
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: