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

Solid Cancers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301716
• Other study ID #: PIM4946g
• Secondary ID: GO01336
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2011
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• GDC-0980
Oral escalating dose
• bevacizumab
Intravenous repeating dose
• carboplatin
Intravenous repeating dose
• cisplatin
intravenous repeating dose
• paclitaxel
Intravenous repeating dose
• pemetrexed
intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first	No
Primary	Incidence of dose limiting toxicities (DLTs)		Up to 21 days from Last Patient In (LPI) in Stage 1 of study	No
Primary	Nature of adverse events		Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first	No
Primary	Nature of dose limiting toxicities (DLTs)		Up to 21 days from Last Patient In (LPI) in Stage 1 of study	No
Primary	Severity of adverse events		Up to 30 days after last dose of study treatment	No
Secondary	Total exposure		Up to 32 months or early study discontinuation	No
Secondary	Maximum plasma concentration		Up to 32 months or early study discontinuation	No
Secondary	Time to maximum observed plasma concentration		Up to 32 months or early study discontinuation	No
Secondary	Plasma half-life		Up to 32 months or early study discontinuation	No