NCT01862081

A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

Completed Phase 1 Last updated 28 November 2017

What this trial tests

Phase 1 trial testing Docetaxel in Breast Cancer, Non-small Lung Cancer in 80 participants. Completed in 9 June 2017.

Timeline

16 July 2013

Primary endpoint
9 June 2017

9 June 2017

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	16 July 2013
Primary completion	9 June 2017
Estimated completion	9 June 2017
Sites	14 locations across Belgium, Canada, United States, Spain

Drugs / interventions tested

• Docetaxel (Docetaxel) — full drug profile →
• GDC-0032
• Paclitaxel — full drug profile →

Conditions studied

• Breast Cancer, Non-small Lung Cancer — all drugs for Breast Cancer, Non-small Lung Cancer →

Sponsor

Genentech, Inc. — full company profile →

Who can join

18 and older, any sex, with Breast Cancer, Non-small Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.
   Mishra R, Patel H, Alanazi S, Kilroy MK, et al · · 2021 · cited 207× · PMID 33801659 · DOI 10.3390/ijms22073464
2. Inhibition of autophagy by chloroquine prevents resistance to PI3K/AKT inhibitors and potentiates their antitumor effect in combination with paclitaxel in triple negative breast cancer models.
   Cocco S, Leone A, Roca MS, Lombardi R, et al · · 2022 · cited 85× · PMID 35761360 · DOI 10.1186/s12967-022-03462-z
3. Phosphatidylinositol 3-kinase (PI3Kα)/AKT axis blockade with taselisib or ipatasertib enhances the efficacy of anti-microtubule drugs in human breast cancer cells.
   Morgillo F, Della Corte CM, Diana A, Mauro CD, et al · · 2017 · cited 27× · PMID 29100327 · DOI 10.18632/oncotarget.20385
4. Correlative studies investigating effects of PI3K inhibition on peripheral leukocytes in metastatic breast cancer: potential implications for immunotherapy.
   Williams CB, Nebhan CA, Yang J, Starnes LS, et al · · 2020 · cited 6× · PMID 32767201 · DOI 10.1007/s10549-020-05846-5
5. A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer.
   Abramson VG, Oliveira M, Cervantes A, Wildiers H, et al · · 2019 · cited 4× · PMID 31368034 · DOI 10.1007/s10549-019-05360-3