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NCT01823835 · ClinicalTrials.gov registry record · Phase 1
A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
A Phase 1 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 1
- Development phase
- 152
- Enrollment target
NCT01823835: Clinical Trial Phase 1 study, sponsored by Genentech.
NCT01823835 is a Phase 1 study that was terminated before completion, run by Genentech. The registered enrollment target is 152 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01823835, a Phase 1 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 152 participants
- Enrollment target
Study Summary
This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety, pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase Ia, Phase Ib, and Phase IIa. During Phase Ia (dose escalation phase), GDC-0810 single agent will be administered orally on a continuous daily dosing regimen with a Day -7 lead-in period for single dose PK evaluation prior to the start of daily treatment. The incidence of dose-limiting toxicities (DLTs) will be evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total). Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0810 using standard 3 + 3 design. During Phase Ib (dose escalation and expansion phase), participants will receive GDC-0810 with palbociclib and/or LHRH agonist to determine the recommended Phase II dose (RP2D) and assess the safety and tolerability of concomitant administration. During Phase IIa (dose expansion phase), participants previously treated with an aromatase inhibitor (AI) will be treated at the RP2D to further characterize the safety, PK, pharmacodynamics, and anti-tumor activity of GDC-0810.
Primary Outcome
Maximum Tolerated Dose (MTD) is determined based on the number of Dose Limiting Toxicities (DLTs) experienced by the participants. DLTs were defined as any of the following adverse events (AEs) that are deemed by the investigator or the Sponsor to be related to study drug (toxicities will be attributed to single agent GDC-0810 unless they are clearly related to disease progression or can clearly be attributed to a cause other than GDC-0810 administration): * Any grade ≥ 3 non-hematologic toxici
Interventions
- DRUG Palbociclib
- DRUG LHRH Agonist
- DRUG GDC-0810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2014-12-29 |
| Est. Completion | 2020-03-13 |
| Phase | Phase 1 |
Why NCT01823835 stopped before completion
NCT01823835 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher).
The record links to 0 conditions, and to 3 interventions - of which Palbociclib is the first listed.
NCT01823835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01823835 about?
NCT01823835 is a clinical study titled "A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer". This study is a multi-institution, Phase Ia/Ib/IIa open-label, dose-finding, safety, pharmacokinetics (PK), and proof-of-concept study of GDC-0810 as a single agent and in combination with palbociclib and/or LHRH agonist. The study is divided into 3 phases: Phase Ia, Phase Ib, and Phase IIa. During ...
What is the current status of trial NCT01823835?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2014-12-29. Estimated completion is 2020-03-13.
What interventions are being tested in trial NCT01823835?
The interventions under investigation include: Palbociclib (DRUG), LHRH Agonist (DRUG), GDC-0810 (DRUG).
Who is sponsoring clinical trial NCT01823835?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01823835's enrollment target sits among peer trials
152 359th of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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