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NCT03006172 · ClinicalTrials.gov registry record · Phase 1
To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
A Phase 1 study of Breast Cancer and Solid Tumor, sponsored by Genentech.
- Active
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 13
- Study locations
NCT03006172 is a Phase 1 study of Breast Cancer and Solid Tumor that is active but no longer recruiting, run by Genentech. The registered enrollment target is 200 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 13 study locations across 6 states.
The verdict
NCT03006172, a Phase 1 study of Breast Cancer and Solid Tumor, is active but no longer recruiting, sponsored by Genentech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Metformin
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Inavolisib
Study Locations (13)
Other
- Institut Bergonie - Bordeaux
- Institut Gustave Roussy - Villejuif
- Hospital Universitari Vall d'Hebron - Barcelona
- Hospital Clinico Universitario de Valencia - Valencia
- St Bartholomew's Hospital - London
- Royal Marsden Hospital - London - London
Massachusetts
- Massachusetts General Hospital. - Boston
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
- Columbia University Medical Center - New York
Tennessee
- SCRI Oncology Partners - Nashville
Ontario
- Princess Margaret Hospital - Toronto
Sutton
- Royal Marsden Hospital - Surrey - Surrey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2016-12-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03006172
The ClinicalTrials.gov registry entry for NCT03006172 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Letrozole is the first listed.
NCT03006172 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT03006172 about?
NCT03006172 is a clinical study titled "To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer". This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with stand...
What is the current status of trial NCT03006172?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2016-12-13. Estimated completion is 2026-12-31.
What conditions does trial NCT03006172 study?
This clinical trial studies the following conditions: Breast Cancer, Solid Tumor.
What interventions are being tested in trial NCT03006172?
The interventions under investigation include: Letrozole (DRUG), Metformin (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Inavolisib (DRUG).
Who is sponsoring clinical trial NCT03006172?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03006172 being conducted?
This trial has 13 study locations across Massachusetts, New York, Tennessee, Ontario, Sutton. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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