TrialSignal
Clinical trial intelligence report
A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT00710528-Jun 25, 2026
NCT ID
NCT00710528
Status
COMPLETED
Phase
Phase 1
Sponsor
Gilead Sciences
Executive brief
Investment-Ready Snapshot
CAL-101, an oral inhibitor of PI3Kδ, is being evaluated for its safety, pharmacokinetics, pharmacodynamics, and clinical activity in patients with relapsed or refractory hematologic malignancies, including CLL, B-cell NHL, AML, and MM. The study's completion in August 2012 positions Gilead Sciences to leverage potential market opportunities in the oncology space, particularly in indications with high unmet medical needs. The competitive landscape includes other PI3K inhibitors, such as idelalisib, which may impact market entry strategies and pricing. Diligence should focus on the drug's safety profile and efficacy data to assess its potential for regulatory approval and market uptake.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00710528
Indication
Chronic Lymphocytic Leukemia (CLL)
Modality
small molecule
Target
Phosphatidylinositol 3-kinase delta (PI3Kδ)
Intervention
CAL-101
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.