Clinical trial · Interventional
A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine
A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
NCT00542893CI-TRIAL-00006455completedPhase 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)
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense
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 Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DTIC alone; then Genasense followed by DTIC | Drug | — | UNRESOLVED |
| Genasense followed by DTIC; then DTIC alone | Drug | — | UNRESOLVED |
| Genasense® (G3139, oblimersen sodium) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
- interventionNames
- Drug: Genasense® (G3139, oblimersen sodium)
- Drug: DTIC alone; then Genasense followed by DTIC
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
- interventionNames
- Drug: Genasense® (G3139, oblimersen sodium)
- Drug: Genasense followed by DTIC; then DTIC alone
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic Stage IV disease, or Stage III disease that is not surgically resectable * ECOG Performance Status of 0, 1, or 2 * Life expectancy of at least 12 weeks * Adequate venous access * Agreement to practice effective method of birth control Exclusion Criteria: * Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy * Significant medical disease * Known hypersensitivity to phosphorothioate-containing oligonucleotides * Known hypersensitivity to DTIC * Pregnancy/Lactation
References
Publications (0)
Data not yet available
No reference posted for this study.