Trial record 1 of 14 for:    gdc0032
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01296555
First received: February 14, 2011
Last updated: July 1, 2016
Last verified: July 2016

February 14, 2011
July 1, 2016
March 2011
September 2019   (final data collection date for primary outcome measure)
  • Area under the concentration-time curve (AUC) of GDC-0032 [ Time Frame: Pre-dose and/or post-dose on Days 1, 2, 3, 4, 8, 9, 15, 16, 22, 23, and 29 of Cycle 1, then on Day 1 of each subsequent cycle ] [ Designated as safety issue: No ]
  • Minimum observed concentration (Cmin) of GDC-0032 [ Time Frame: Pre-dose and/or post-dose on Days 1, 2, 3, 4, 8, 9, 15, 16, 22, 23, and 29 of Cycle 1, then on Day 1 of each subsequent cycle ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of GDC-0032 [ Time Frame: Pre-dose and/or post-dose on Days 1, 2, 3, 4, 8, 9, 15, 16, 22, 23, and 29 of Cycle 1, then on Day 1 of each subsequent cycle ] [ Designated as safety issue: No ]
  • Incidence of adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) grade and associated dose of GDC-0032 [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]
  • Incidence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0032 [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II: Clinical benefit rate with the combination GDC-0032 + fulvestrant [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II: Objective response rate with the combination GDC-0032 + fulvestrant [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Days 1-35 ] [ Designated as safety issue: No ]
  • Incidence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01296555 on ClinicalTrials.gov Archive Site
  • Phase I: Best overall response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase I: Duration of objective response [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase I: Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II: Duration of response with the combination GDC-0032 + fulvestrant [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II: PFS with the combination GDC-0032 + fulvestrant [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II: Overall survival with the combination GDC-0032 + fulvestrant [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Best overall response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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 (PO) 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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma, Solid Cancers
  • Drug: Fulvestrant
    Select cohorts, as described in the Arms section, will receive fulvestrant 500 milligrams (mg) via intramuscular injection on Days 1 and 15 of Cycle 1, then on Day 1 of each subsequent cycle, 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 PO once daily in 28-day cycles.
  • Drug: Letrozole
    Select cohorts, as described in the Arms section, will receive letrozole 2.5 mg PO once daily in 28-day cycles until disease progression.
  • 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 PO daily in 28-day cycles. Dose escalation decisions will be based upon the observed incidence of DLTs.
    Intervention: Drug: GDC-0032
  • Experimental: Phase I, Stage 2: GDC-0032 + Fulvestrant
    Select indication-specific cohorts (F, J, K, L, and M) will receive GDC-0032 administered PO in combination with fulvestrant until disease progression.
    Interventions:
    • Drug: Fulvestrant
    • Drug: GDC-0032
  • Experimental: Phase I, Stage 2: GDC-0032 + Letrozole
    Select indication-specific cohorts (E, N, P, Q, R, and S) will receive GDC-0032 administered PO in combination with letrozole until disease progression.
    Interventions:
    • Drug: GDC-0032
    • Drug: Letrozole
  • Experimental: Phase I, Stage 2: GDC-0032 as Single Agent
    Select indication-specific cohorts (A, B, C, D, G, H, T, and X) will receive GDC-0032 administered PO until disease progression.
    Intervention: Drug: GDC-0032
  • 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 administered PO daily in combination with fulvestrant until disease progression.
    Interventions:
    • Drug: Fulvestrant
    • Drug: GDC-0032
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
724
September 2019
September 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Phase I (Cohorts A through D, G, H, T, 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 patients 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 Response Evaluation Criteria version 1.1 (RECIST v1.1)
  • Phase I (Cohort T): Greater than or equal to (>/=) 1 bi-dimensionally measurable lesion on computed tomography (CT) scan
  • Phase I (Cohort X): 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 14 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
Both
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: PMT4979g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
United States,   Canada,   France,   Spain
 
NCT01296555
PMT4979g, GO00886
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP