Clinical trial · Interventional
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
NCT00735332CI-TRIAL-00003745terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): License termination.
Summary
Brief summary (as posted)
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TLN-232 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-Arm
- interventionNames
- Drug: TLN-232
Primary outcomes (1)
- measure
- To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
- timeFrame
- Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Secondary outcomes (1)
- measure
- To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
- timeFrame
- Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous) * First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them) * Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1 * Age ≥ 18 years * ECOG ≤ 2 * Normal organ and marrow function as defined below: * Leukocytes ≥2.5 x 109/L * Absolute neutrophil count ≥1.5 x 109/L * Platelets ≥100 x 109/L * Hemoglobin ≥100 g/L (10g/dL) * Total bilirubin ≤1.5 X institutional ULN * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN * Creatinine ≤1.5 X institutional ULN Exclusion Criteria: * Patients with a life expectancy ≤ 16 weeks * Patients with ocular melanoma * Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1 * Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues * Patients with a documented history of HIV, active hepatitis B or C infection * Female patients who are pregnant or lactating * Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted) * Patients with grade ≥2 peripheral neuropathy (CTCAE criteria) * Patients in whom a proper central line cannot be established
References
Publications (0)
Data not yet available
No reference posted for this study.