deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00710528

Dose Escalation Study of CAL-101 in Select Relapsed or Refractory Hematologic Malignancies

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

Sponsor: Gilead Sciences

Interventions CAL-101
Updated 7 times since 2017 Last updated: Aug 29, 2012 Started: Jun 30, 2008 Primary completion: Dec 31, 2011 Completion: Aug 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00710528, this PHASE1 trial focuses on Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL) and remains completed. Sponsored by Gilead Sciences, it has been updated 7 times since 2008, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.

A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Jun 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gilead Sciences
Data source: Gilead Sciences

For direct contact, visit the study record on ClinicalTrials.gov .