Clinical trial · Interventional
A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin
A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.
Summary
Brief summary (as posted)
The purpose of the first part of the study is to evaluate the safety, tolerability, and pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin given to patients with advanced solid tumors, and to select a dose for further evaluation in the second part of the study. The purpose of the second part of the study is to determine the safety, tolerability, and exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO-1.01 and Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CO-1.01 and Cisplatin
- interventionNames
- Drug: CO-1.01 and Cisplatin
Primary outcomes (4)
- measure
- Dose limiting toxicities (DLT)(Part 1)
- timeFrame
- From time taking first dose of CO-1.01 (Cycle 1 Day 1) through last day of Cycle 1 (Cycle 1 Day 21), an expected average of 6 weeks.
- measure
- Adverse events (Description of event in medical terminology, Intensity, Relationship to drug, Outcome, and/or Follow up )(Part 2)
- timeFrame
- From time of signing informed consent form through 28 days after last dose of CO-1.01, an expected average of 7 weeks
- measure
- Clinical Laboratory Abnormalities (ANC, Platelets, Hemoglobin, AST/ALT, Bilirubin, Creatinine clearance)(Part 2)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Understand and sign institutional review board/independent ethics committee-approved informed consent form (ICF) prior to any study-specific evaluation * Life expectancy of at least 3 months * ECOG performance status of 0 to 1 * ≥ 18 years at the time ICF is signed * Adequate hematological and biological function * Histologically or cytologically confirmed solid tumor malignancy (Part 1 only) * Histologically or cytologically confirmed stage IIIb/IV NSCLC (Part 2 only) Exclusion Criteria: * Symptomatic central nervous system metastases * Concomitant treatment with prohibited medications, e.g. other chemotherapy, radiation, hormonal treatment (excepting corticosteroids), or immunotherapy ≤ 14 days prior to CO-1.01 treatment * Treatment with a previous regimen of CO-1.01 * Participation in another therapeutic clinical study within 14 days of enrollment or during this clinical study * Surgical procedures ≤ 14 days prior to CO-1.01 administration * History of allergy to gemcitabine, gemcitabine elaidate or eggs * Known allergic/hypersensitivity reaction to cisplatin, other platinum agent, or platinum containing compounds * Peripheral neuropathy ≥ Grade 1 * Females who are pregnant or breastfeeding * Refusal to use adequate contraception for fertile patients * Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study * Any other reason the investigator considers the patient should not participate in the study
References
Publications (0)
Data not yet available