Phase 1
Completed N=50
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Source: ClinicalTrials.gov NCT00635778 ↗Enrolled (actual)
50
Serious AEs
56.0%
Results posted
Oct 2018
Primary outcomePrimary: Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose — 4.78; 7.48; 54.57; 33.00 μg/mL
Summary
The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose |
4.78; 7.48; 54.57; 33.00; 25.95; 24.39 | — |
| PRIMARY Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1 |
118.56 | — |
| SECONDARY Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer |
0; 0; 0; 2; 1; 1 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5 |
150.94 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9 |
150.69 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13 |
138.11 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17 |
140.72 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21 |
150.00 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25 |
157.49 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29 |
174.95 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33 |
158.95 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37 |
186.32 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41 |
173.68 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45 |
140.00 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49 |
137.89 | — |
| SECONDARY Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53 |
198.99 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function
Exclusion Criteria
- Participant is using growth hormones or growth hormone inhibitors
- Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
- Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
- Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate
- Participant is pregnant or breastfeeding
- Participant is human immunodeficiency virus (HIV) positive
- Participant has a history of Hepatitis B or C
- Participant has symptomatic ascites or pleural effusion. However, if the participant has received treatment and is stable, they may be able to participate
- Female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing
Data sourced from ClinicalTrials.gov (NCT00635778). 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.