deltatrials
Completed PHASE1 NCT01392976

Safety and Pharmacokinetic Profiles of Two Formulations of CO-1.01 in Patients With Advanced Solid Tumors

A Phase I, Open-Label, Two-stage, Randomized, Crossover, Comparative Pharmacokinetic and Safety Study of Two Formulations of CO-1.01 for Injection in Patients With Advanced Solid Tumors

Sponsor: Clovis Oncology, Inc.

Conditions Advanced Solid Tumor
Interventions CO-1.01 Formulation A (Aqueous suspension containing 15 mg/mL of drug solubilized in purified phospholipids) CO-1.01 Formulation B (Aqueous suspension containing 30 mg/mL of drug solubilized in purified phospholipids)
Updated 6 times since 2017 Last updated: Aug 13, 2014 Started: Apr 30, 2011 Primary completion: Oct 31, 2011 Completion: Apr 30, 2013

A PHASE1 clinical study on Advanced Solid Tumor, this trial is completed. The trial is conducted by Clovis Oncology, Inc. and has accumulated 6 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Apr 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Clovis Oncology, Inc.
Data source: Clovis Oncology, Inc.

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

Study Locations

  • • Amsterdam, Netherlands
  • • Maastricht, Netherlands
  • • Utrecht, Netherlands