Clinical trial · Interventional
Study of NK012 in Patients With Refractory Solid Tumors
A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors
NCT00542958CI-TRIAL-00041313completedPhase 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 determine whether NK012 is safe and effective in the treatment of refractory 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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK012 | Drug | 7-Ethyl-10-Hydroxycamptothecin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK012
- description
- This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1\*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/\*28) variants as one group, and patients with UGT1A1\*28 homozygous variant (\*28/\*28) as another group. Dose-escalation in each patient population will proceed according to the predefined dose level. For UGT1A1\*28 (wt/wt and wt/\*28) patients, at least 3 evaluable patients will be treated at each dose level. UGT1A1 homozygous (\*28/\*28) patients will be treated at 50% of the current dose level. Patients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study.
- interventionNames
- Drug: NK012
Primary outcomes (3)
- measure
- Dose-limiting toxicity of NK012 in patients with UGT1A1*28 (wt/wt and wt/*28) genotype
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority * Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist * Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss) * Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1 * 18 years of age or older * Adequate kidney, liver, and bone marrow function * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier * Receiving any other investigational agent * History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for \> 1 week * History of allergic reactions attributed to compounds of similar chemical composition to NK012 * Concurrent serious infections (i.e., requiring an intravenous antibiotic) * Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements * Significant cardiac disease * History of serious ventricular arrhythmia * Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies
References
Publications (0)
Data not yet available
No reference posted for this study.