Phase 2
Completed N=144
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
Source: ClinicalTrials.gov NCT00246012 ↗Enrolled (actual)
144
Serious AEs
22.5%
Results posted
Aug 2013
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 |
0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) |
94.44; 199.45; 306.86 | — |
| PRIMARY Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) |
257.55; 503.71; 1479.07 | — |
| PRIMARY Half-life of Intetumumab - Phase 1 (Part 1) |
2.03; 2.13; 5.33 | — |
| PRIMARY Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1) |
11.85; 9.96; 6.79 | — |
| PRIMARY Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1) |
34.69; 30.63; 50.80 | — |
| PRIMARY Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1) |
— | — |
| PRIMARY Progression-Free Survival (PFS) - Phase 2 |
54.0; 42.0; 42.0; 75.0 | — |
| SECONDARY Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2 |
9.7; 0; 6.1; 3.3 | — |
| SECONDARY Percentage of Participants Who Achieved CR - Phase 2 |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2 |
32.3; 25.8; 24.2; 53.3 | — |
| SECONDARY Overall Survival (OS) - Phase 2 |
233.0; 298.0; 426.0; 333.5 | — |
| SECONDARY Duration of Response - Phase 2 |
— | — |
| SECONDARY Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2 |
135.0; 226.0; 194.0; 170.0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2 |
NA; 131.18; 240.81; 219.47 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2 |
53.8; 55.6; 55.3; 53.3; -2.2; -1.9 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2 |
1.3; 2.0; 0.9; 2.2; 0.9; 0.0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2) |
118.47; 220.87 | — |
| SECONDARY Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2) |
368.74; 963.17 | — |
| SECONDARY Half-life of Intetumumab - Phase 1 (Part 2) |
2.41; 2.36 | — |
| SECONDARY Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2) |
13.44; 10.34 | — |
| SECONDARY Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2) |
47.38; 35.18 | — |
| SECONDARY Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed melanoma including ocular and mucosal
- Documented AJCC (American Joint Committee on Cancer) Stage 3 unresectable or Stage 4 melanoma (Phase 1); AJCC Stage 4 melanoma (Phase 2)
- Radiographically measurable disease or measurable skin lesions
- Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while previously untreated for melanoma by chemotherapy will be allowed for Phase 2
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria
- History of receiving murine or human/murine recombination products of human αν integrins
- Known human immunodeficiency virus (HIV) positivity and clinically important active infection
- Presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases
- Prior radiation to target lesions
- Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation
Data sourced from ClinicalTrials.gov (NCT00246012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.