Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | July 11, 2011 |
End Date: | June 30, 2019 |
A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide 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 ipatasertib (GDC-0068) administered in
combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU)
(mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or
metastatic solid tumors for which standard therapy either does not exist or has proven
ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics
of ipatasertib administered in combination with enzalutamide in participants with metastatic
castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this
study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1,
approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be
evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given
combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to
further characterize the safety and tolerability of ipatasertib in these combinations and to
confirm a potential recommended Phase II dose of ipatasertib for each regimen.
NOTE: Arms A, B, and C are closed.
safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in
combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU)
(mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or
metastatic solid tumors for which standard therapy either does not exist or has proven
ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics
of ipatasertib administered in combination with enzalutamide in participants with metastatic
castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this
study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1,
approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be
evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given
combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to
further characterize the safety and tolerability of ipatasertib in these combinations and to
confirm a potential recommended Phase II dose of ipatasertib for each regimen.
NOTE: Arms A, B, and C are closed.
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Histologically or cytologically documented advanced or metastatic solid tumors for
which established therapy either does not exist or has proven ineffective or
intolerable
- Life expectancy greater than or equal to (>=) 12 weeks
- Adequate hematologic and end organ function
- For female participants of childbearing potential and male participants with partners
of childbearing potential, agreement (by participant and/or partner) to use highly
effective forms of contraception and to continue its use for the duration of the study
and for 4 months after last dose of study treatment (for females) and 6 months after
last dose of study treatment (for males)
Exclusion Criteria:
- Prior anti-cancer therapy that fulfills the following criteria: a total of more than
three (Arms A and B) or two (Arms C and D) prior cytotoxic chemotherapy regimens,
high-dose chemotherapy requiring stem-cell support, and irradiation to >=25 percent
(%) of bone marrow-bearing areas
- Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy,
oral contraceptives, or gonadotropin-releasing hormone (GnRH) agonists or antagonists
for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except
palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4
weeks prior to initiation of ipatasertib. Exceptions are kinase inhibitors approved by
local regulatory authorities, which may be used within 2 weeks prior to initiation of
ipatasertib, provided that any clinically-relevant drug-related toxicity has
completely resolved and prior approval is obtained from the Medical Monitor
- Palliative radiation to bony metastases within 2 weeks prior to initiation of
ipatasertib
- History of Type 1 or Type 2 diabetes requiring regular medication
- Grade >= 2 heart failure or history of unstable angina
- History of clinically significant ventricular arrhythmias or active ventricular
arrhythmia requiring medication
- For Arm D only: History of seizure, unexplained loss of consciousness, transient
ischemic attack within 12 months of enrollment, cerebral vascular accident, and any
brain metastases
We found this trial at
8
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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