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NCT00790816
An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors
Phase 1 trial testing Lapatinib in combination with an anti-cancer agent in Neoplasms, Breast in 500 participants. Completed in 19 August 2016.
19 August 2016
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 1 October 2008 |
| Primary completion | 19 August 2016 |
| Estimated completion | 19 August 2016 |
| Sites | 23 locations across United States, Canada, Netherlands, South Korea, Spain |
Drugs / interventions tested
- Lapatinib in combination with an anti-cancer agent — full drug profile →
- Lapatinib (LAPATINIB) — full drug profile →
- Lapatinib in combination with an anti-cancer agent as specified by parent protocol — full drug profile →
Conditions studied
- Neoplasms, Breast — all drugs for Neoplasms, Breast →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Neoplasms, Breast. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability
Time frame: Initiation of study treatment to discontinuation of study treatment
Sponsor's own description
This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00790816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neoplasms, Breast
Currently open trials in the same condition.
- NCT06819215 — Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT04915755 — Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HE · Phase 3 · active not recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT00790816 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 26 February 2018
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/NCT00790816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing