Clinical trial · Interventional
Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies
Phase I Trial Of Cisplatin And KML-001 In Advanced Non-Small Cell Lung Cancer and Other Platinum Responsive Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity was not felt to be acceptable for further development.
Summary
Brief summary (as posted)
This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity. In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer, Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Platinum Responsive Malignancies | Lung Small Cell Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| KML-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Period 1: KML001 15mg plus Cisplatin 75mg/m2
- description
- KML001 15 mg orally daily days 1-14 with cisplatin IV on day1
- interventionNames
- Drug: KML-001
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Period 2: KML001 17.5mg plus Cisplatin 75mg/m2
- description
- KML001 17.5 mg orally daily days 1-14 with cisplatin IV on day1
- interventionNames
- Drug: KML-001
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Period 3: KML001 20mg plus Cisplatin 75mg/m2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer or other "platinum responsive malignancies" , including but not limited to: esophageal cancer, ovarian cancer, germ cell malignancies , transitional cell cancer etc. that are not curable with chemotherapy, surgery or radiotherapy. A tissue block or fresh tissue biopsy is required. Patients with CNS (Central Nervous System) metastases which are symptomatic must have received therapy (surgery, X Ray Therapy (XRT), gamma knife) and be neurologically stable and off steroids. Patients with asymptomatic lesions without significant edema and no evidence of shift are allowed to participate without prior CNS therapy. Such patients are anticipated to receive specific CNS therapy after 2-4 courses of therapy. * Patients may have received prior systemic chemotherapy or radiation therapy. At least 2 weeks should have elapsed since the last treatment and patients should have recovered from previous significant toxicity (i.e. to grade 1 or less). Alopecia, skin discoloration etc. are not considered significant toxicities. There is no limit on the number of prior therapies. Patients may have received prior cisplatin or other platinum regimens. * Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. * Patient 18 years of age or older. * Absolute Granulocyte Count greater than or equal to 1.5 x 10\^9 * Platelet count greater than or equal to 100 x 10\^9 * Serum creatinine within normal limits, or an estimated or measured creatinine clearance greater than or equal to 65 ml/min. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. * Serum calcium, magnesium and potassium must be within normal limits. Exclusion Criteria: * Patients must not have serious infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment. These need not be specified in the history and physical and can be documented through signature on the eligibility checklist. Severe, active co-morbidity, defined as follows: 1. Current uncontrolled cardiac disease; 2. Corrected (Bazett) QTc interval of \> .50 ms (male) or \> .52 ms (female); 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; 4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 4 weeks of registration; 5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; 6. Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition or patients known to be HIV positive. * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. * Pre-existing ≥ grade 2 peripheral neuropathy.
References
Publications (1)
- RESULTPhatak P, Dai F, Butler M, Nandakumar MP, Gutierrez PL, Edelman MJ, Hendriks H, Burger AM. KML001 cytotoxic activity is associated with its binding to telomeric sequences and telomere erosion in prostate cancer cells. Clin Cancer Res. 2008 Jul 15;14(14):4593-602. doi: 10.1158/1078-0432.CCR-07-4572. PMID 18628474