A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

September 3, 2021 updated by: Genentech, Inc.

An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

686

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - University Health Network; Princess Margaret Hospital; Medical Oncology Dept
France
- - Villejuif, France, 94805
    - Institut Gustave Roussy
Spain
- - Barcelona, Spain, 08035
    - Hospital Univ Vall d'Hebron; Servicio de Oncologia
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
United States
- Arizona
  - Scottsdale, Arizona, United States, 85258
    - TGen Clinical Research Srvs
  - Tucson, Arizona, United States, 85719
    - University of Arizona Cancer Center
- California
  - Orange, California, United States, 92868
    - University of California Irvine Medical Center
  - Sacramento, California, United States, 95817
    - UC Davis; Comprehensive Cancer Center
  - San Francisco, California, United States, 94109
    - Sutter Health
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale University
- Florida
  - Fort Myers, Florida, United States, 33901-8101
    - Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
  - Sarasota, Florida, United States, 34232
    - Sarah Cannon Res Inst; FL
- Illinois
  - Chicago, Illinois, United States, 60637
    - Univ of Chicago
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
  - Boston, Massachusetts, United States, 02115
    - Dana Farber Cancer Inst.
- Michigan
  - Detroit, Michigan, United States, 48201
    - Barbara Ann Karmanos Cancer Institute
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Washington University; Division of Oncology
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, P.C.
  - New York, New York, United States, 10065
    - Memorial Sloan-Kettering Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Sarah Cannon Res Inst; OK
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - West Cancer Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt
  - Nashville, Tennessee, United States, 37203
    - Sarah Cannon Res Inst; TN Onc
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center; Vanderbilt Health Pharmacy
- Texas
  - Abilene, Texas, United States, 79606-5208
    - Texas Cancer Center
  - Dallas, Texas, United States, 75246
    - Baylor Sammons Cancer Center
  - Dallas, Texas, United States, 75230
    - Mary Crowley Cancer Rsch Ctr
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center
  - Tyler, Texas, United States, 75702
    - USO - Tyler Cancer Ctr
- Washington
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists - Vancouver
  - Yakima, Washington, United States, 98902
    - Yakima Valley Memorial Hospital/North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Phase I (Cohorts A through D, G, H, T, T2 and X): Histologically documented, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit
Phase I (Cohorts E and F): Post-menopausal females with locally advanced or metastatic hormone receptor-positive breast cancer that has progressed or failed to respond to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase II: Post-menopausal female participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer
Phase I (Cohorts A through S) and Phase II: Evaluable or measurable disease per RECIST version 1.1
Phase I (Cohorts T, and T2): Greater than or equal to (>/=) 1 bi-dimensionally measurable lesion on computed tomography (CT) scan
Phase I (Cohort T): Participants with non-Hodgkin's lymphoma, regardless of PIK3CA mutation status
Phase 1 (Cohort T2): Participants with diffuse large B-cell lymphoma (DLBCL), regardless of PIK3CA mutation status
Phase I (Cohort X): Participants with PIK3CA-mutant tumors and measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Screening
Life expectancy of >/= 12 weeks
Adequate hematologic and organ function within 28 days prior to initiation of study treatment
Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment)
Active congestive heart failure or ventricular arrhythmia requiring medication
Participants requiring any daily supplemental oxygen
Active inflammatory disease requiring immunosuppressants, including small or large intestinal inflammation such as Crohn's disease or ulcerative colitis
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Treatment with chemotherapy less than or equal to (</=) 3 weeks before study treatment
Oral endocrine therapy </= 2 weeks before study treatment
Treatment with investigational drug </= 3 weeks or 5 half-lives before study treatment
Treatment with biologic therapy </= 3 weeks before study treatment
Treatment with kinase inhibitors </= 2 weeks before study treatment
Radiation therapy (other than radiation to bony metastases) as cancer therapy </= 4 weeks before study treatment
Palliative radiation therapy to bony metastases </= 2 weeks before study treatment
Major surgery </= 4 weeks before study treatment
Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participant at high risk from treatment complications (examples include but are not limited to clinically significant non-healing wound, active bleeding, or ongoing fistula or active tuberculosis infection)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I, Stage 1: GDC-0032 as Single Agent Participants with locally advanced or metastatic solid tumors will receive increasing doses of GDC-0032 administered orally daily in 28-day cycles. Dose escalation decisions will be based upon the observed incidence of DLTs.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles.
Experimental: Phase I, Stage 2: GDC-0032 + Fulvestrant Participants (Cohorts F, J, K, L, and M) will receive GDC-0032 in combination with fulvestrant until disease progression.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles. Drug: Fulvestrant Participants will receive fulvestrant 500 milligrams (mg) via intramuscular injection (as per package insert or Summary of Product Characteristics [SmPC]) on Days 1 and 15 of Cycle 1, then on Day 1 of each subsequent cycle, until disease progression (Cycle length: 28 days). Other Names: Faslodex®
Experimental: Phase I, Stage 2: GDC-0032 + Letrozole Participants (Cohorts E, N, P, Q, R, and S) will receive GDC-0032 in combination with letrozole until disease progression.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles. Drug: Letrozole Participants will receive letrozole 2.5 mg orally (as per Package Insert or SmPC) once daily in 28-day cycles until disease progression. Other Names: Femara®
Experimental: Phase I, Stage 2: GDC-0032 as Single Agent Participants (Cohorts A, B, C, D, G, H, T, T2, and X) will receive GDC-0032 until disease progression.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles.
Experimental: Phase I, Stage 2: GDC-0032 + Midazolam Participants (Cohort C) will receive GDC-0032 in combination with midazolam.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles. Drug: Midazolam Participants will receive midazolam 5 mg (as per Package Insert or SmPC) in hydrochloride syrup on Days 1 and 16 of Cycle 1.
Experimental: Phase II: GDC-0032 + Fulvestrant Post-menopausal females with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer will receive GDC-0032 in combination with fulvestrant until disease progression.	Drug: GDC-0032 Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles. Drug: Fulvestrant Participants will receive fulvestrant 500 milligrams (mg) via intramuscular injection (as per package insert or Summary of Product Characteristics [SmPC]) on Days 1 and 15 of Cycle 1, then on Day 1 of each subsequent cycle, until disease progression (Cycle length: 28 days). Other Names: Faslodex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I Stage I: Percentage of Participants With Adverse Events and Serious Adverse Events Time Frame: Baseline up to approximately 5 years		Baseline up to approximately 5 years
Phase 1 Stage 1: Percentage of Participants With Dose-Limiting Toxicities Time Frame: Baseline up to 35 days		Baseline up to 35 days
Phase I Stage 1: Maximum Tolerated Dose of GDC-0032 Time Frame: Baseline up to 35 days		Baseline up to 35 days
Phase I: Area Under the Concentration-Time Curve (AUC) From Zero to Infinity of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr);1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22;thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2,Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15;Predose (0-2 hr) on Cycle 1 Days 8, 16;thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days)	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: AUC From Zero to tau (AUCtau) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Maximum Observed Concentration (Cmax) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Minimum Observed Concentration (Cmin) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Time to Reach Cmax (tmax) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Half-life (t1/2) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Apparent Clearance (CL/F) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Accumulation Ratio (AR) (Area Under the Concentration Time Curve at Steady-State Divided by Area Under the Concentration Time Curve for First Dose) of GDC-0032 Time Frame: Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)	Detailed timeframe: Stage 1: Predose (0-2 hr), 0.5, 1, 2, 3, 4, 8, 24 (Days 1 and 15), 48, 72 hr (Day 1 only) postdose, Cycle 1; Predose (0-2 hr) on Days 8, 22, 29 of Cycle 1 and on Day 1 of each subsequent cycle up to Study Completion/Early Termination (approximately 5 years) (cycle length: 35 days for Cycle 1, 28 days for other cycles). Stage 2, Cohort A: Predose (0-2 hr); 1, 2, 3, 4, 8, 24 hr postdose on Cycle 1 Days 1, 8, 22; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts B, D, G: Predose (0-2 hr), 3 hr postdose on Cycle 1 Days 1, 15; Predose (0-2 hr) on Cycle 1 Days 8, 16; thereafter predose (0-2 hr) on Day 1 of each cycle up to study completion/early termination (approximately 5 years) (Cycle length: 28 days). Stage 2, Cohorts H, T, T2, X: Predose (0-4 hr) on Day 15 Cycle 1 and Day 1 of Cycles 2, 6. Additionally 3 hr postdose on Day 15 Cycle 1 (Cycle length: 28 days).	Baseline up to approximately 5 years (Detailed cohort-wise timeframe is given in the description)
Phase I: Recommended Dose of Single-Agent GDC-0032 Time Frame: Baseline up to 35 days		Baseline up to 35 days
Phase II: Percentage of Participants With Clinical Benefit, as Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)		Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Phase II: Percentage of Participants With Objective Response, as Assessed Using RECIST Version 1.1 Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)		Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2011

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

PMT4979g
GO00886 (Other Identifier: Hoffmann-La Roche)
2012-002042-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Active, not recruiting

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

Hematopoietic and Lymphoid Cell Neoplasm | Advanced Lymphoma | Advanced Malignant Solid Neoplasm | Refractory Lymphoma | Refractory Malignant Solid Neoplasm | Refractory Multiple Myeloma

United States
Southwest Oncology Group
National Cancer Institute (NCI)

Completed

Lung-MAP: Taselisib as Therapy in Treating Patients With Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches

Recurrent Squamous Cell Lung Carcinoma | Stage IV Squamous Cell Lung Carcinoma

United States, Canada
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI); Genentech, Inc.; Translational Breast Cancer... and other collaborators

Terminated

Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer

Stage IV Breast Cancer | Estrogen Receptor Negative | Estrogen Receptor Positive | HER2/Neu Negative | Progesterone Receptor Negative | Progesterone Receptor Positive | Triple-Negative Breast Carcinoma

United States
Genentech, Inc.

Completed

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

Breast Cancer, Non-small Lung Cancer

United States, Spain, Canada, Belgium
Hoffmann-La Roche

Terminated

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER)

Breast Cancer

Italy, United States, Korea, Republic of, Canada, Czechia, Spain, Australia, Bulgaria, China, Finland, France, Greece, Poland, Portugal, Taiwan, Thailand, Turkey, Colombia, Bosnia and Herzegovina, Mexico, Peru, Romania, Russian Federation and more
The Netherlands Cancer Institute
Genentech, Inc.; EurocanPlatform; Rather

Completed

Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen (Poseidon)

Breast Cancer

Spain, Netherlands, France, United Kingdom
Genentech, Inc.
Breast International Group; SOLTI Breast Cancer Research Group; Austrian Breast...

Completed

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Breast Cancer

United States, United Kingdom, Germany, Australia, Austria, Belgium, Brazil, France, Guatemala, Italy, Korea, Republic of, Panama, Poland, Portugal, Spain, Czechia, Hungary, Mexico, Peru, Switzerland, El Salvador, Chile
Genentech, Inc.

Completed

A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

Healthy Volunteers

United States

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Study Overview

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Studies a U.S. FDA-regulated drug product

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