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NCT01991184
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.
Phase 1 trial testing GDC-0853 in Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma in 24 participants. Completed in 8 March 2022.
8 March 2022
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 16 December 2013 |
| Primary completion | 8 March 2022 |
| Estimated completion | 8 March 2022 |
| Sites | 10 locations across United States, Australia |
Drugs / interventions tested
- GDC-0853 — full drug profile →
Conditions studied
- Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma — all drugs for Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Managing toxicities of Bruton tyrosine kinase inhibitors.
Lipsky A, Lamanna N. · · 2020 · cited 112× · PMID 33275698 · DOI 10.1182/hematology.2020000118 -
BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.
Alu A, Lei H, Han X, Wei Y, et al · · 2022 · cited 88× · PMID 36183125 · DOI 10.1186/s13045-022-01353-w -
Targeting Bruton tyrosine kinase using non-covalent inhibitors in B cell malignancies.
Gu D, Tang H, Wu J, Li J, et al · · 2021 · cited 69× · PMID 33676527 · DOI 10.1186/s13045-021-01049-7 -
First-in-human phase 1 study of the BTK inhibitor GDC-0853 in relapsed or refractory B-cell NHL and CLL.
Byrd JC, Smith S, Wagner-Johnston N, Sharman J, et al · · 2018 · cited 65× · PMID 29560128 · DOI 10.18632/oncotarget.24310 -
The Role of Bruton's Kinase Inhibitors in Chronic Lymphocytic Leukemia: Current Status and Future Directions.
Robak T, Witkowska M, Smolewski P. · · 2022 · cited 42× · PMID 35159041 · DOI 10.3390/cancers14030771 -
Overcoming resistance to targeted therapies in chronic lymphocytic leukemia.
Skånland SS, Mato AR. · · 2021 · cited 42× · PMID 33570649 · DOI 10.1182/bloodadvances.2020003423 -
Overcoming Ibrutinib Resistance in Chronic Lymphocytic Leukemia.
Puła B, Gołos A, Górniak P, Jamroziak K. · · 2019 · cited 38× · PMID 31766355 · DOI 10.3390/cancers11121834 -
Btk Inhibitors: A Medicinal Chemistry and Drug Delivery Perspective.
Brullo C, Villa C, Tasso B, Russo E, et al · · 2021 · cited 36× · PMID 34299259 · DOI 10.3390/ijms22147641
Verify or expand the search:
- PubMed search for NCT01991184
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GDC-0853
Trials testing the same drug.
- NCT03693625 — A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebruti · Phase 2 · terminated
- NCT03407482 — An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus · Phase 2 · terminated
- NCT03137069 — A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU). · Phase 2 · completed
- NCT03174041 — A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin · Phase 1 · completed
- NCT03290703 — A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Heal · Phase 1 · completed
Other Genentech, Inc. trials
Trials by the same sponsor.
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- NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01991184 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
- Last refreshed: 21 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01991184.
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