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

NCT01301716 | Completed Phase 1

• 2 other identifiers: PIM4946gGO01336
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 5

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.

Conditions

Solid Cancers

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

  Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first

• Incidence of dose limiting toxicities (DLTs)

  Up to 21 days from Last Patient In (LPI) in Stage 1 of study

• Nature of adverse events

  Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first

• Nature of dose limiting toxicities (DLTs)

  Up to 21 days from Last Patient In (LPI) in Stage 1 of study

• Severity of adverse events

  Up to 30 days after last dose of study treatment

Secondary Outcomes (4)

• Total exposure

  Up to 32 months or early study discontinuation

• Maximum plasma concentration

  Up to 32 months or early study discontinuation

• Time to maximum observed plasma concentration

  Up to 32 months or early study discontinuation

• Plasma half-life

  Up to 32 months or early study discontinuation

Study Arms (3)

A

EXPERIMENTAL

Drug: GDC-0980; Drug: carboplatin; Drug: paclitaxel

B

EXPERIMENTAL

Drug: GDC-0980; Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel

C

EXPERIMENTAL

Drug: GDC-0980; Drug: cisplatin; Drug: pemetrexed

Interventions

GDC-0980 DRUG

Oral escalating dose

A; B; C

bevacizumab DRUG

Intravenous repeating dose

B

carboplatin DRUG

Intravenous repeating dose

A; B

cisplatin DRUG

intravenous repeating dose

C

paclitaxel DRUG

Intravenous repeating dose

A; B

pemetrexed DRUG

intravenous repeating dose

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (5)

Unknown Facility

Los Angeles, California, 90025, United States

Location

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Madrid, Madrid, 28050, Spain

Location

MeSH Terms

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one; Bevacizumab; Carboplatin; Cisplatin; Paclitaxel; Pemetrexed

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 23, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

ES (1); US (4)