A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

NCT00854126 | Completed Phase 1

• 2 other identifiers: PIM4605gMP00881
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 3

Brief Summary

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.

Conditions

Non-Hodgkin's Lymphoma, Solid Cancers

Keywords

NHL; Solid Tumors; Carcinogenic Tumors

Outcome Measures

Primary Outcomes (4)

• Occurrence of adverse events

  Length of study

• Occurrence of dose-limiting toxicities

  Length of study

• Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980

  Length of study

• PK parameters after doses of GDC-0980

  Length of study

Secondary Outcomes (2)

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

  Length of study

• PET response for patients with detectable FDG tumor uptake at baseline

  Length of study

Study Arms (1)

1

EXPERIMENTAL

Drug: GDC-0980

Interventions

GDC-0980 DRUG

Escalating repeating dose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
• A biopsy-accessible lesion from which tissue can be obtained safely
• Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN \>= 2 weeks apart prior to initiation of study treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
• Life expectancy \>= 12 weeks
• Adequate hematologic and organ function within 28 days before initiation of GDC-0980
• Documented willingness to use an effective means of contraception for both men and women while participating in the study
• For patients participating in DCE-MRI assessments: at least one metastatic lesion measuring \>/= 3 cm in the liver or \>/= 2 cm elsewhere (lung and mediastinum lesions are ineligible) in at least one dimension (on CT scan)

You may not qualify if:

• Leptomeningeal disease as the only manifestation of the current malignancy
• 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
• Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for \>= 3 months
• Congenital long QT syndrome or screening QTc \> 470 msec
• Active congestive heart failure or ventricular arrhythmia requiring medication
• Ejection fraction that is \<50% or is below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
• Active infection requiring IV antibiotics
• Requirement for any daily supplemental oxygen
• DLCO \< 50% of predicted value corrected for hemoglobin and alveolar volume
• Uncontrolled hypomagnesemia
• Hypercalcemia requiring continued use of bisphosphonate therapy
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Uncontrolled ascites requiring frequent paracentesis

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Moein A, Jin JY, Wright MR, Alicke B, Wong H. Retrospective Assessment of Translational Pharmacokinetic-Pharmacodynamic Modeling Performance: A Case Study with Apitolisib, a Dual PI3K/mTOR Inhibitor. Drugs R D. 2024 Jun;24(2):155-167. doi: 10.1007/s40268-024-00459-5. Epub 2024 May 3.

  PMID: 38700808 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mika Derynck, M.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: February 27, 2009
• First Posted: March 3, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1); US (1); GB (1)