N/A
Completed N=93
A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel
Neoplasms
Source: ClinicalTrials.gov NCT01251653 ↗
Enrolled (actual)
93
Serious AEs
60.2%
Results posted
May 2016
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). — 0; 1; 1; 2 Participants
Summary
To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.
To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). |
0; 1; 1; 2; 2; 4 | — |
| SECONDARY The Incidence and Intensity of AEs With Grading According to CTCAE. |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Best Overall Response According to RECIST v1.1 Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Disease Control According to RECIST v1.1 |
1; 3; 6; 1; 2; 8 | — |
| SECONDARY Objective Response According to RECIST v1.1 |
3; 6; 15; 6; 2; 17 | — |
| SECONDARY Time to Objective Response According to RECIST v1.1 |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Duration of Objective Response According to RECIST v1.1 |
291.0; 138.3; 410.0; 296.0; 55.5 | — |
| SECONDARY Duration of Disease Control According to RECIST v1.1 |
119.5; 210.0; 119.7; 77.4; 207.1; 233.6 | — |
| SECONDARY Progression Free Survival (PFS) |
23.9; 18.1; 23.6 | — |
| SECONDARY Overall Survival (OS) |
52.4; 38.4; NA | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib |
1000.0; 1230.0; 642.0; 746.0; 557.0; 723.0 | 0.4815 |
| SECONDARY Cmax,ss of Afatinib |
58.1; 66.4; 33.9; 45.6; 33.9; 45.7 | 0.8715 |
| SECONDARY AUC 0-tz of Gemcitabine |
9610.0; 7120.0 | 0.7759 |
| SECONDARY Cmax of Gemcitabine |
16000.0; 13500.0 | 0.3359 |
| SECONDARY Total Clearance (CL) of Gemcitabine |
3020.0; 4090.0 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Gemcitabine |
90.5; 106.0 | — |
| SECONDARY AUC 0-24 of Docetaxel |
2000.0; 2210.0; 2400.0; 2270.0 | 0.0349 sig |
| SECONDARY Cmax of Docetaxel |
1690.0; 1860.0; 1790.0; 2080.0 | 0.0728 |
| SECONDARY Total Clearance (CL) of Docetaxel |
811.0; 671.0; 886.0; 892.0 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Docetaxel |
255.0; 315.0; 323.0; 300.0 | — |
Eligibility Criteria
Inclusion criteria
- histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor.
Exclusion criteria
- Active brain metastases
- Patients with known pre-existing interstitial lung disease
Data sourced from ClinicalTrials.gov (NCT01251653). 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.