Table 1 Patient characteristics and clinical outcome.

From: Phase 1 safety and pharmacodynamic study of lenalidomide combined with everolimus in patients with advanced solid malignancies with efficacy signal in adenoid cystic carcinoma

Variable

Level

N (%) = 44

Age (years)

Median

58

Gender

Male

28 (63.6)

Female

16 (36.4)

Race

White

32 (72.7)

Asian or other

4 (9.1)

African American

8 (18.2)

Ethnicity

Hispanic or Latino

3 (6.8)

Non-Hispanic

40 (90.9)

Unknown

1 (2.3)

DLT

No

18 (40.9)

NE

3 (6.8)

RP2D

22 (50.0)

Yes

1 (2.3)

Histologic type

Adenoid cystic

15 (34.1)

Renal cell carcinoma

9 (20.5)

Thyroid cancer

5 (11.4)

Other

15 (34.1)

Dose cohorts

1: Lenalidomide/everolimus (10/5 mg)

3 (7.0)

2: Lenalidomide/everolimus (15/5 mg)

3 (7.0)

3: Lenalidomide/everolimus (20/5 mg)

5 (12.8)

4: Lenalidomide/everolimus (25/5 mg)

3 (7.0)

5: Lenalidomide/everolimus (25/10 mg)

8 (18.6)

RP2D: L (25 mg) and E (10 mg)

22 (51.2)

Best response

PD

7 (16.3)

PR

5 (11.6)

SD

24 (55.8)

NE

7 (16.3)

OS (months)

Median

33 (1.22–73.59)

TTF (months)

Median

3.45 (0.46–35.49)

Number of cycles

Mean

7.77

Median

5.00

  1. Summary of demographic characteristics, tumour histology, dose cohort assignment and efficacy outcome in study patients.
  2. DLT dose-limiting toxicity, RP2D recommended phase 2 dose, SD stable disease, PR partial response, PD pharmacodynamic, NE not evaluable, TTF time to treatment failure, OS overall survival.
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