NCT01090960

Brief Summary

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

4.9 years

First QC Date

March 19, 2010

Last Update Submit

July 1, 2016

Conditions

Solid Cancers

Outcome Measures

Primary Outcomes (4)

  • Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068

    Through study completion or early study discontinuation

  • Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068

    Through study completion or early study discontinuation

  • Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068

    Through study completion or early study discontinuation

  • PK parameters after single and multiple doses of GDC-0068

    Through study completion or early study discontinuation

Secondary Outcomes (1)

  • Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST

    Through study completion or early study discontinuation

Study Arms (1)

A

EXPERIMENTAL
Drug: GDC-0068

Interventions

GDC-0068DRUG

Oral repeating dose

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable.
  • Evaluable or measurable disease
  • Life expectancy \>= 12 weeks
  • Adequate hematologic and organ function within 14 days before initiation of GDC-0068
  • Documented willingness to use an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for both men and women while participating in the study

You may not qualify if:

  • History of Type 1 or 2 diabetes mellitus requiring regular medication
  • Grade \> 2 hypercholesterolemia or hypertriglyceridemia
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Leptomeningeal disease as the only manifestation of the current malignancy
  • Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for \>= 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Valencia, Valencia, 46010, Spain

Location

Related Publications (3)

  • Malhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1.

    PMID: 34471960DERIVED

  • Saura C, Roda D, Rosello S, Oliveira M, Macarulla T, Perez-Fidalgo JA, Morales-Barrera R, Sanchis-Garcia JM, Musib L, Budha N, Zhu J, Nannini M, Chan WY, Sanabria Bohorquez SM, Meng RD, Lin K, Yan Y, Patel P, Baselga J, Tabernero J, Cervantes A. A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors. Cancer Discov. 2017 Jan;7(1):102-113. doi: 10.1158/2159-8290.CD-16-0512. Epub 2016 Nov 21.

    PMID: 27872130DERIVED

  • De Mattos-Arruda L, Weigelt B, Cortes J, Won HH, Ng CKY, Nuciforo P, Bidard FC, Aura C, Saura C, Peg V, Piscuoglio S, Oliveira M, Smolders Y, Patel P, Norton L, Tabernero J, Berger MF, Seoane J, Reis-Filho JS. Capturing intra-tumor genetic heterogeneity by de novo mutation profiling of circulating cell-free tumor DNA: a proof-of-principle. Ann Oncol. 2014 Sep;25(9):1729-1735. doi: 10.1093/annonc/mdu239. Epub 2014 Jul 9.

    PMID: 25009010DERIVED

MeSH Terms

Interventions

ipatasertib

Study Officials

  • Premal Patel, M.D., Ph.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 23, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

ES(2)