A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors
This study is currently recruiting participants.
Verified May 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01562275
First received: March 21, 2012
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: GDC-0973 Drug: GDC-0068 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of GDC-0973 and GDC-0068 in Patients With Locally Advanced or Metastatic Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence of dose-limiting toxicities [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Nature of dose-limiting toxicities [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Estimation of the maximum tolerated dose [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Nature of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Severity of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Incidence of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Nature of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Severity of serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters of GDC-0973 and GDC-0068: total exposure [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of GDC-0973 and GDC-0068: maximum plasma concentration [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of GDC-0973 and GDC-0068: minimum concentration [ Time Frame: Days 1, 8, and 15 pre-dose and up to 24 h post-dose for Cycle 1 and Day 1 on Cycles 2 and 3 ] [ Designated as safety issue: No ]
- Objective response for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Duration of objective response for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
- Progression-free survival for patients with measurable disease according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0973
multiple doses
Drug: GDC-0068
multiple doses
|
| Experimental: B |
Drug: GDC-0973
multiple doses
Drug: GDC-0068
multiple doses
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically documented locally advanced or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable
- Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
- Life expectancy >/= 12 weeks
- Adequate hematologic and end organ function
Exclusion Criteria:
- History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
- History of prior significant toxicity from another PI3K or Akt pathway or mTOR inhibitor requiring discontinuation of treatment
- Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated in protocol
- History of type I or type II diabetes mellitus requiring insulin
- Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease)
- Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B or hepatitis C virus
- Active autoimmune disease
- Pregnant or lactating women
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- History of glaucoma
- History of retinal vein occlusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562275
Contacts
| Contact: Reference Study ID Number: GE28079 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Recruiting | |
| Detroit, Michigan, United States, 48201 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01562275 History of Changes |
| Other Study ID Numbers: | GE28079 |
| Study First Received: | March 21, 2012 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
MEK GDC0973 Akt inhibitor |
MEK inhibitor GDC0068 Akt |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013