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GDC-0980

Phase 2

Endometrial Carcinoma | Small molecule | Oncology |Roche Holding AG|Trials Updated: Nov 2, 2016

GDC-0980 development status

Highest phase Phase 2
Registered trials 10 across 1 sponsor since Mar 2009

GDC-0980 target and mechanism

ModalitySmall molecule

Also known as [14C]-GDC-0980

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials7
Total Enrollment468

FDA Designations

No designations recorded

GDC-0980 clinical trials

GDC-0980 · 7 trials · 5 indications

Phase 2 2Phase 1 5
NCT01455493A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial CarcinomaEndometrial Carcinoma
COMPLETED56 Analytics
NCT01442090Study of GDC-0980 Versus Everolimus in Participants With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted TherapyRenal Cell Carcinoma
COMPLETED85 Analytics
PHASE2COMPLETED
A Study of GDC-0980 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Endometrial CarcinomaUnlock trial analytics
PHASE2COMPLETED
Study of GDC-0980 Versus Everolimus in Participants With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following Vascular Endothelial Growth Factor- (VEGF) Targeted Therapy
Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective tumor response as assessed by the investigator using RECIST v1.1
up to approximately 23 months
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
at 6 months
DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1
Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Incidence of adverse events
Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Incidence of dose limiting toxicities (DLTs)
Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Nature of adverse events
Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Nature of dose limiting toxicities (DLTs)
Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Severity of adverse events
Up to 30 days after last dose of study treatment
Nature of adverse events graded according to NCI CTCAE, v4.0
Up to 30 days after last dose of study treatment
Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0
Up to 28 days
Incidence and nature of dose-limiting toxicities (DLTs)
Through Day 22
Incidence, nature, and severity of adverse events
Through study completion, up to 1 year, or early discontinuation
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 Endpoints

Overall survival (OS), defined as the time from treatment initiation until death from any cause
up to approximately 36 months
Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1
up to approximately 23 months
Incidence of adverse events
up to approximately 23 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
EverolimusACTIVE_COMPARATORParticipants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980EXPERIMENTALParticipants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
BEXPERIMENTAL -
CEXPERIMENTAL -
1EXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0980DRUGOral daily dose
EverolimusDRUGEverolimus will be administered orally at a 10 mg daily dose.
bevacizumabDRUGIntravenous repeating dose
carboplatinDRUGIntravenous repeating dose
cisplatinDRUGintravenous repeating dose
paclitaxelDRUGIntravenous repeating dose
pemetrexedDRUGintravenous repeating dose
capecitabineDRUGOral repeating dose
mFOLFOX6DRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites28

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 ...

Countries:United StatesFranceGermanySpainUnited KingdomBelgium
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Frequently asked questions about GDC-0980

What is GDC-0980?

GDC-0980 is an investigational small molecule developed by Roche Holding AG for oncology. It has been studied in breast cancer, endometrial carcinoma, non-Hodgkin's lymphoma, renal cell carcinoma, and other solid cancers. It is not approved and remains in clinical development.

What is GDC-0980 used for in endometrial carcinoma?

GDC-0980 was studied in a Phase 2 trial for recurrent or persistent endometrial carcinoma. That trial, NCT01455493, enrolled 56 female participants aged 18 and older in the United States and has completed. GDC-0980 is investigational and has not been approved for this or any indication.

Who is developing GDC-0980?

GDC-0980 is developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche sponsored the clinical program evaluating the compound across several tumor types, including endometrial carcinoma, renal cell carcinoma, and advanced solid tumors.

What phase is GDC-0980 in?

GDC-0980 has been evaluated in Phase 1 and Phase 2 clinical trials, all of which are completed. No trials are currently active. The compound is investigational and has not received FDA approval for any indication.

What clinical trials is GDC-0980 in?

GDC-0980 has been studied in completed trials including NCT01455493 in endometrial carcinoma, NCT01442090 comparing it with everolimus in metastatic renal cell carcinoma, NCT01332604 in advanced solid tumors, and NCT01301716 in solid tumors. These trials enrolled a combined total of 257 participants.

Is GDC-0980 the same as [14C]-GDC-0980?

Yes, [14C]-GDC-0980 is an alternative name for GDC-0980. The bracketed label refers to the carbon-14 radiolabeled form used in study work. Both names refer to the same Roche investigational small molecule being evaluated in oncology.