Clinical trial · Interventional
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
NCT01392976CI-TRIAL-00015396completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the pharmacokinetic and safety profiles of two formulations of CO-1.01 in patients with Advanced Solid Tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO-1.01 Formulation A (Aqueous suspension containing 15 mg/mL of drug solubilized in purified phospholipids) | Drug | — | UNRESOLVED |
| CO-1.01 Formulation B (Aqueous suspension containing 30 mg/mL of drug solubilized in purified phospholipids) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CO-1.01 Formulation B
- interventionNames
- Drug: CO-1.01 Formulation B (Aqueous suspension containing 30 mg/mL of drug solubilized in purified phospholipids)
- type
- ACTIVE_COMPARATOR
- label
- CO-1.01 Formulation A
- interventionNames
- Drug: CO-1.01 Formulation A (Aqueous suspension containing 15 mg/mL of drug solubilized in purified phospholipids)
Primary outcomes (1)
- measure
- Ratio of the AUC0-∞ of the two formulations of CO-1.01 given as a 30 min i.v. infusion at 1250 mg/m2
- timeFrame
- Serum & urine PK sampling at multiple timepoints through Cycle 1: Day 1 & Day 8
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis with a histologically confirmed solid tumor malignancy that is metastatic or unresectable for which there is no standard curative or palliative treatment option available and for which CO-1.01 treatment would be appropriate * Life expectancy of at least 3 months * Performance status (ECOG)0 or 1 * Age ≥18 years * Adequate hematological and biological function * Written consent on an Institutional Review Board/Independent Ethics Committee-approved IC Form prior to any study-specific evaluation Exclusion Criteria: * Clinically significant abnormal 12-lead ECG or QTcF\>450msec (males) or \>470 msec (females), PR\>240 msec, or a QRS\>110msec * Family history of long QT syndrome * Implantable pacemaker or implantable cardioverter defibrillator * Symptomatic brain metastases * Concomitant treatment with prohibited medications * Treatment with a previous regimen of CO-1.01 within 30 days or randomization * Treatment with any medication known to produce QT prolongation * Surgical procedures are not allowed ≥14 days prior to administration of CO-1.01. In all cases, the patient must be sufficiently recovered and stable * History of allergy to gemcitabine or eggs * Females who are pregnant or breastfeeding * Refusal to use adequate contraception for fertile patients (females and males) for 6 months after the last dose of CO-1.01 * Presence of any serious of unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism) * Any other reason the investigator considers the patient should not participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.