SPECTRUM PHARMACEUTICALS, INC.
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1987-01-01
- Employees
- 101
- Market Cap
- -
- Website
- http://www.sppirx.com
Clinical Trials
103
Trial Phases
3 Phases
Drug Approvals
1
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (81 trials with phase data)• Click on a phase to view related trials
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
- First Posted Date
- 2022-05-18
- Last Posted Date
- 2025-07-16
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Target Recruit Count
- 268
- Registration Number
- NCT05378763
- Locations
- 🇺🇸
Bond Clinic, P.A., Winter Haven, Florida, United States
A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2021-07-29
- Last Posted Date
- 2021-09-05
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Target Recruit Count
- 74
- Registration Number
- NCT04981704
- Locations
- 🇺🇸
Celerion, Phoenix clinical facility, Tempe, Arizona, United States
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
- First Posted Date
- 2020-09-30
- Last Posted Date
- 2025-07-16
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Target Recruit Count
- 40
- Registration Number
- NCT04570423
- Locations
- 🇺🇸
New York Medical College, Valhalla, New York, United States
🇺🇸Carolinas Medical Center/ Levine Children's Hospital, Charlotte, North Carolina, United States
🇺🇸Levine Children's Health, Charlotte, North Carolina, United States
Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects
- Conditions
- Healthy
- Interventions
- Drug: [14C]-Poziotinib
- First Posted Date
- 2020-06-18
- Last Posted Date
- 2021-01-15
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Target Recruit Count
- 8
- Registration Number
- NCT04436562
- Locations
- 🇺🇸
Covance Clinical Research Unit, Inc., Madison, Wisconsin, United States
Study of Poziotinib in Japanese Patients With NSCLC
- Conditions
- NSCLC
- Interventions
- First Posted Date
- 2020-05-26
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Target Recruit Count
- 42
- Registration Number
- NCT04402008
- Locations
- 🇯🇵
National Cancer Center East, Kashiwa, Chiba, Japan
🇯🇵Osaka City General Hospital, Miyakojima-ku, Osaka, Japan
🇯🇵Shizuoka Cancer Center, Sunto District, Shizuoka, Japan
- Prev
- 1
- 2
- 3
- 4
- 5
- 12
- Next
News
FDA Rejects Poziotinib for HER2-Mutated NSCLC Following Advisory Committee's Negative Vote
• The FDA has issued a complete response letter for poziotinib, Spectrum Pharmaceuticals' pan-HER2 inhibitor, rejecting its application for HER2 exon 20 insertion-mutated non-small cell lung cancer treatment. • The rejection follows a 9-4 vote against approval by FDA's Oncologic Drugs Advisory Committee, citing concerns over marginal efficacy, high toxicity rates, and delayed confirmatory trials. • Phase 2 ZENITH20 study showed limited efficacy with 28% objective response rate and five-month median response duration, while 12% of patients discontinued due to adverse effects.