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AzTrials

Breast Cancer, Non-small Lung CancerPhase 1NCT01862081

A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

A Phase 1 study testing Docetaxel, GDC-0032 and Paclitaxel in people with Breast Cancer, Non-small Lung Cancer, run by Genentech, Inc. at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Non-small Lung Cancer
What is being tested?
Docetaxel, GDC-0032 and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
14 sitesin 4 countries
Study dates
16 Jul 2013to 9 Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >=18 years
  • For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
  • For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC
  • For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
  • Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
  • Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1
Show all 10Show fewer
  • Life expectancy >=12 weeks
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
  • Adequate hematologic and end organ function
  • Use of highly effective form of contraception

Who cannot join

  • Prior anti-cancer therapy
  • Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
  • Known significant hypersensitivity to any components of study treatment
  • Grade >=2 peripheral neuropathy
  • Type 1 or Type 2 diabetes
  • Grade >=2 hypercholesterolemia or hypertriglyceridemia
  • Congenital long QT syndrome
  • Active congestive heart failure or ventricular arrhythmia

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Texas Oncology, P.A; Baylor Sammons Cancer Center

    Dallas, Texas, 75231

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Specialists - Tampa (Dr. MLK Blvd)

    Tampa, Florida, 33607

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Belgium1 site

  • UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy

    Leuven, 3000

Other trials in Belgium

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M4X 1K9

Other trials in Canada

About this study

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.

Being tested
Docetaxel, GDC-0032, Paclitaxel
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.

  • GDC-0032Drug

    Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.

  • PaclitaxelDrug

    Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.

Study groups in NCT01862081
Study groupRoleWhat they receive
Arm A: GDC-0032 + DocetaxelExperimentalParticipants will receive GDC-0032 once daily for 21 consecutive days (beginning from Day 1) in each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Receives: Drug: Docetaxel; Drug: GDC-0032
Arm B: GDC-0032 + PaclitaxelExperimentalParticipants will receive GDC-0032 once daily for 28 consecutive days (beginning from Day 1) in each 28-day cycle along with Paclitaxel on Days 1, 8, 15 and 22 of each 28-day cycle.
Receives: Drug: GDC-0032; Drug: Paclitaxel
Arm C: GDC-0032 + DocetaxelExperimentalParticipants will receive GDC-0032 once daily on Day 1 and Days 8-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Receives: Drug: Docetaxel; Drug: GDC-0032
Arm D: GDC-0032 + DocetaxelExperimentalParticipants will receive GDC-0032 once daily on Days 2-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Receives: Drug: Docetaxel; Drug: GDC-0032
Arm E: GDC-0032 + DocetaxelExperimentalParticipants will receive GDC-0032 once daily on Days 1-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle.
Receives: Drug: Docetaxel; Drug: GDC-0032
Arm F: GDC-0032 + PaclitaxelExperimentalParticipants will receive GDC-0032 once daily on a 5-days on, 2-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle.
Receives: Drug: GDC-0032; Drug: Paclitaxel
Arm G: GDC-0032 + PaclitaxelExperimentalParticipants will receive GDC-0032 once daily on a 3-days on, 4-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle.
Receives: Drug: GDC-0032; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Incidence of adverse events

    Measured: Approximately 3 years

  2. Safety: Incidence of dose limiting toxicities

    Measured: Up to 28 days

Secondary outcomes (7)

  1. Area under the curve from time 0 to the last measurable concentration (AUC0-last)

    Measured: Up to 28 days

  2. Time to maximum observed plasma concentration (Tmax)

    Measured: Up to 28 days

  3. Maximum observed plasma concentration (Cmax)

    Measured: Up to 28 days

  4. Minimum observed plasma concentration (Cmin)

    Measured: Up to 28 days

  5. Objective response according to RECIST v1.1

    Measured: Approximately 3 years

  6. Duration of response according to RECIST v1.1

    Measured: Approximately 3 years

  7. Progression-free survival (PFS) according to RECIST v1.1

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2013 (estimated)
  2. Study start16 Jul 2013
  3. Primary completion9 Jun 2017
  4. Study completion9 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01862081
Sponsor's protocol ID
GO27802
Other IDs
2013-003543-28
Status last verified
Nov 2017
First submitted
22 May 2013
Last updated
28 Nov 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel, GDC-0032 and Paclitaxel in people with Breast Cancer, Non-small Lung Cancer, run by Genentech, Inc. at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Spain, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence of adverse events (time frame: Approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01862081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.

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