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ACTIVE NOT RECRUITING 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

NCT03006172 · View on ClinicalTrials.gov ↗

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)).

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

FieldValue
Enrollment Target 200 participants
Start Date 2016-12-13
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Genentech

206 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03006172 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03006172?

The interventions under investigation include: Letrozole (DRUG), Metformin (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Inavolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03006172?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial