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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

NCT ID: NCT01301716

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Cancers

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

GDC-0980

Intervention Type DRUG

Oral escalating dose

carboplatin

Intervention Type DRUG

Intravenous repeating dose

paclitaxel

Intervention Type DRUG

Intravenous repeating dose

B

Group Type EXPERIMENTAL

GDC-0980

Intervention Type DRUG

Oral escalating dose

bevacizumab

Intervention Type DRUG

Intravenous repeating dose

carboplatin

Intervention Type DRUG

Intravenous repeating dose

paclitaxel

Intervention Type DRUG

Intravenous repeating dose

C

Group Type EXPERIMENTAL

GDC-0980

Intervention Type DRUG

Oral escalating dose

cisplatin

Intervention Type DRUG

intravenous repeating dose

pemetrexed

Intervention Type DRUG

intravenous repeating dose

Interventions

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GDC-0980

Oral escalating dose

Intervention Type DRUG

bevacizumab

Intravenous repeating dose

Intervention Type DRUG

carboplatin

Intravenous repeating dose

Intervention Type DRUG

cisplatin

intravenous repeating dose

Intervention Type DRUG

paclitaxel

Intravenous repeating dose

Intervention Type DRUG

pemetrexed

intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Los Angeles, California, United States

Site Status

Tampa, Florida, United States

Site Status

Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Madrid, Madrid, Spain

Site Status

Countries

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United States Spain

Other Identifiers

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GO01336

Identifier Type: OTHER

Identifier Source: secondary_id

PIM4946g

Identifier Type: -

Identifier Source: org_study_id