Clinical trial · Interventional
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
A Multicenter, Single-Arm, Open-Label, Phase II Study of GDC-0980 for The Treatment of Recurrent or Persistent Endometrial Carcinoma
NCT01455493CI-TRIAL-00023446completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0980 | Drug | Apitolisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0980
Primary outcomes (2)
- measure
- Objective tumor response as assessed by the investigator using RECIST v1.1
- timeFrame
- up to approximately 23 months
- measure
- Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study
- timeFrame
- at 6 months
Secondary outcomes (5)
- measure
- Overall survival (OS), defined as the time from treatment initiation until death from any cause
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have recurrent or persistent endometrial carcinoma that is refractory to curative therapy or established treatments * Histologic confirmation of the original primary tumor is required * Histologic or cytologic confirmation of the recurrent/progressive disease is desired * Patients must have had at least one but no more than two prior chemotherapeutic regimens for management of endometrial carcinoma * Disease that is measurable per RECIST v1.1 * No active infection requiring antibiotics * Any hormonal therapy directed at the malignant tumor must be discontinued at least 2 weeks prior to first study treatment * Any other prior therapy directed at the malignant tumor, including immunologic agents and radiotherapy, must be discontinued at least 2 weeks prior to first study treatment * Adequate hematologic and end organ function Exclusion Criteria: * Type I diabetes or Type II diabetes requiring insulin * Prior use of mTOR/PI3K inhibitor * Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living * Previous diagnosis of pulmonary fibrosis of any cause * History of myocardial infarction or unstable angina within 6 months prior to first study treatment * Congestive heart failure * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant history of liver disease, including cirrhosis and current alcohol abuse * Presence of positive test results for hepatitis B or hepatitis C * Known HIV infection * Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs * Need for current chronic corticosteroid therapy * Pregnancy, lactation, or breastfeeding * Current severe, uncontrolled systemic disease * Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment * Uncontrolled hypercalcemia * Leptomeningeal disease as a manifestation of cancer * Known untreated or active brain metastases * Grade \>=2 hypercholesterolemia or hypertriglyceridemia
References
Publications (0)
Data not yet available
No reference posted for this study.