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G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455829
Recruitment Status : Completed
First Posted : March 7, 2018
Results First Posted : May 1, 2023
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
G1 Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Non-Small-Cell Lung
Lung Cancer
Non-small Cell Lung Cancer
Interventions Drug: G1T38
Drug: Osimertinib
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Hide Arm/Group Description Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Period Title: Overall Study
Started 7 6 4 7 6
Completed 0 0 0 0 0
Not Completed 7 6 4 7 6
Reason Not Completed
Death             2             3             2             4             2
Study terminated and patients did not have progressive disease or died             5             3             2             2             3
Disease progression             0             0             0             1             1
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID Total
Hide Arm/Group Description Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally Total of all reporting groups
Overall Number of Baseline Participants 7 6 4 7 6 30
Hide Baseline Analysis Population Description
All enrolled patients who were administered at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 4 participants 7 participants 6 participants 30 participants
62.71  (11.265) 62.67  (8.779) 62.75  (7.805) 61.43  (15.757) 66.17  (3.764) 63.10  (10.118)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 4 participants 7 participants 6 participants 30 participants
Female
6
  85.7%
3
  50.0%
3
  75.0%
5
  71.4%
4
  66.7%
21
  70.0%
Male
1
  14.3%
3
  50.0%
1
  25.0%
2
  28.6%
2
  33.3%
9
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 4 participants 7 participants 6 participants 30 participants
Hispanic or Latino
3
  42.9%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
4
  13.3%
Not Hispanic or Latino
3
  42.9%
6
 100.0%
3
  75.0%
5
  71.4%
6
 100.0%
23
  76.7%
Unknown or Not Reported
1
  14.3%
0
   0.0%
1
  25.0%
1
  14.3%
0
   0.0%
3
  10.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 4 participants 7 participants 6 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  14.3%
1
  16.7%
1
  25.0%
0
   0.0%
1
  16.7%
4
  13.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
1
  16.7%
3
  10.0%
White
1
  14.3%
5
  83.3%
2
  50.0%
3
  42.9%
4
  66.7%
15
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  71.4%
0
   0.0%
1
  25.0%
2
  28.6%
0
   0.0%
8
  26.7%
1.Primary Outcome
Title Dose Limiting Toxicity
Hide Description

The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including:

  • Grade 4 neutropenia
  • ≥ Grade 3 neutropenic infection/febrile neutropenia
  • Grade 4 thrombocytopenia
  • ≥ Grade 3 thrombocytopenia with bleeding
  • ≥ Grade 3 nonhematologic toxicity (additional criteria for nausea, vomiting, diarrhea, or fatigue: lasting > 5 days with maximal medical management)
  • Liver function test abnormalities meeting Hy's Law criteria (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥ 3 × upper limit of normal [ULN] and total bilirubin ≥ 2 × ULN).
Time Frame Cycle 1 Day -16 to Cycle 1 Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: including all enrolled patients who were administered at least 1 dose of study drug.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 6 4 7 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description

Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause.

Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments were used to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All enrolled patients who were administered at least one dose of continuous daily G1T38.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 6 4 6 6
Median (95% Confidence Interval)
Unit of Measure: months
19.3 [1] 
(2.0 to NA)
6.0 [1] 
(1.8 to NA)
1.4 [1] 
(0.7 to NA)
7.2 [1] 
(1.6 to NA)
12.9 [1] 
(3.6 to NA)
[1]
The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.
3.Secondary Outcome
Title Best Overall Tumor Response
Hide Description

The percentage of patients who fall into each category of Best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.
Time Frame 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
The response evaluable analysis set includes all patients who received study drug, had a measurable lesion (target lesions) at the baseline tumor assessment, and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have a post-baseline tumor assessment but had clinical progression as noted by the investigator, or died due to disease progression before their first post-baseline tumor scan.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 6 6 4 7 5
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response (PR)
2
  33.3%
1
  16.7%
0
   0.0%
1
  14.3%
3
  60.0%
Stable Disease (SD)
2
  33.3%
4
  66.7%
1
  25.0%
3
  42.9%
0
   0.0%
Progressive Disease (PD)
1
  16.7%
1
  16.7%
3
  75.0%
2
  28.6%
1
  20.0%
Not Evaluable (NE)
1
  16.7%
0
   0.0%
0
   0.0%
1
  14.3%
1
  20.0%
4.Secondary Outcome
Title Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax)
Hide Description The observed peak plasma concentration determined from the plasma concentration versus time data.
Time Frame Part 1, Cycle 1 Day -16 to Day -2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included only those patients that received G1T38 on a once daily schedule, that is Cohorts 1-3. Pharmacokinetic data for Cohorts 4 and 5 were not collected due to the twice daily dosing schedule implemented, per recommendation of the Safety Monitoring Committee, for these 2 cohorts.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 4 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
G1T38 Cycle 1 Day -16 27.229  (8.936) 33.375  (12.212) 43.850  (21.942)
G1T38 Cycle 1 Day -2 17.257  (1.471) 26.400  (2.689) 42.700  (25.107)
Metabolite G1T30 Cycle 1 Day -16 3.080  (1.301) 3.568  (0.633) 4.220  (1.717)
Metabolite G1T30 Cycle 1 Day -2 2.736  (0.764) 3.853  (1.146) 5.970  (4.369)
5.Secondary Outcome
Title Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity
Hide Description Area under the concentration-time curve from time zero extrapolated to infinity using the linear-up log-down trapezoidal rule.
Time Frame Part 1, Cycle 1 Day -16 to Day -2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included only those patients that received G1T38 on a once daily schedule, that is Cohorts 1-3. Pharmacokinetic data for Cohorts 4 and 5 were not collected due to the twice daily dosing schedule implemented, per recommendation of the Safety Monitoring Committee, for these 2 cohorts.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 4 4
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
G1T38 Cycle 1 Day -16 319.6  (107) 391.0  (85.6) 715.6  (359)
G1T38 Cycle 1 Day -2 277.4  (63.2) 390.0  (91.0) 802.3  (519)
Metabolite G1T30 Cycle 1 Day -16 28.443  (17.175) 30.853  (10.577) 53.971  (23.638)
Metabolite G1T30 Cycle 1 Day -2 30.110  (11.255) 44.745  (13.929) 80.145  (66.239)
6.Secondary Outcome
Title Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2)
Hide Description Terminal half-life, defined as 0.693 divided by the terminal phase rate constant by λz , determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.
Time Frame Part 1, Cycle 1 Day -16 to Day -2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included only those patients that received G1T38 on a once daily schedule, that is Cohorts 1-3. Pharmacokinetic data for Cohorts 4 and 5 were not collected due to the twice daily dosing schedule implemented, per recommendation of the Safety Monitoring Committee, for these 2 cohorts.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 4 4
Mean (Standard Deviation)
Unit of Measure: hour
G1T38 Cycle 1 Day -16 13.83  (1.95) 16.30  (4.36) 15.59  (2.12)
G1T38 Cycle 1 Day -2 13.59  (2.88) 12.61  (1.71) 13.93  (2.14)
Metabolite G1T30 Cycle 1 Day -16 11.771  (7.248) 12.238  (8.072) 22.614  (3.297)
Metabolite G1T30 Cycle 1 Day -2 13.722  (8.025) 18.220  (2.027) 18.582  (2.977)
7.Secondary Outcome
Title Pharmacokinetics of G1T38: Plasma - Volume of Distribution
Hide Description

Volume of distribution in the terminal elimination phase, calculated as:

Vz/F = (CL/F)/λz
Time Frame Part 1, Cycle 1 Day -16 to Day -2.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included only those patients that received G1T38 on a once daily schedule, that is Cohorts 1-3. Pharmacokinetic data for Cohorts 4 and 5 were not collected due to the twice daily dosing schedule implemented, per recommendation of the Safety Monitoring Committee, for these 2 cohorts.
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD
Hide Arm/Group Description:
Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally
Overall Number of Participants Analyzed 7 4 4
Mean (Standard Deviation)
Unit of Measure: Liter
G1T38 Cycle 1 Day -16 14000  (6540) 18700  (6910) 15900  (9210)
G1T38 Cycle 1 Day -2 14900  (4660) 14800  (5060) 12900  (6490)
Time Frame The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of lerociclib/osimertnib, an average of 11 months for each participant (Mean exposure + 30 days/1 month).
Adverse Event Reporting Description An AE is defined as any untoward medical occurrence in a patient administered a medicinal product that does not necessarily have a causal relationship with this treatment, but does not include Progression of the malignancy under study. Deaths which were unequivocally due to disease progression, were documented in the eCRF module, but were not reported as SAEs during the study.
 
Arm/Group Title Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Hide Arm/Group Description Part 1: G1T38/Lerociclib at 200 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 300 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 400 mg once daily (QD) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 150 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally Part 1: G1T38/Lerociclib at 200 mg twice daily (BID) orally + Osimertinib 80 mg once daily (QD) orally
All-Cause Mortality
Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)      3/6 (50.00%)      2/4 (50.00%)      4/7 (57.14%)      2/6 (33.33%)    
Hide Serious Adverse Events
Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      1/6 (16.67%)      1/4 (25.00%)      0/7 (0.00%)      2/6 (33.33%)    
Infections and infestations           
COVID-19 pneumonia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Sepsis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders           
Ischaemic stroke * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pneumonitis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Pneumothorax * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Pulmonary embolism * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1: Cohort 1 Lerociclib at 200 mg QD Part 1: Cohort 2 Lerociclib at 300 mg QD Part 1: Cohort 3 Lerociclib at 400 mg QD Part 1: Cohort 4 Lerociclib at 150 mg BID Part 1: Cohort 5 Lerociclib at 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      6/6 (100.00%)      4/4 (100.00%)      7/7 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders           
Anaemia * 1  5/7 (71.43%)  34 2/6 (33.33%)  4 2/4 (50.00%)  3 1/7 (14.29%)  5 0/6 (0.00%)  0
Leukopenia * 1  4/7 (57.14%)  35 2/6 (33.33%)  7 1/4 (25.00%)  1 1/7 (14.29%)  2 0/6 (0.00%)  0
Neutropenia * 1  4/7 (57.14%)  22 3/6 (50.00%)  7 1/4 (25.00%)  1 2/7 (28.57%)  4 0/6 (0.00%)  0
Lymphopenia * 1  3/7 (42.86%)  13 1/6 (16.67%)  4 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Thrombocytopenia * 1  3/7 (42.86%)  3 3/6 (50.00%)  4 1/4 (25.00%)  3 1/7 (14.29%)  3 0/6 (0.00%)  0
Thrombocytosis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0
Cardiac disorders           
Tachycardia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders           
Ear pain * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Eye disorders           
Vision blurred * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Conjunctival haemorrhage * 1  1/7 (14.29%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Visual impairment * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Dry eye * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Eye pain * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Lacrimation increased * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Vitreous detachment * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders           
Diarrhoea * 1  5/7 (71.43%)  18 6/6 (100.00%)  13 4/4 (100.00%)  10 6/7 (85.71%)  6 6/6 (100.00%)  11
Nausea * 1  5/7 (71.43%)  10 5/6 (83.33%)  7 3/4 (75.00%)  6 2/7 (28.57%)  2 3/6 (50.00%)  3
Vomiting * 1  5/7 (71.43%)  7 4/6 (66.67%)  5 2/4 (50.00%)  4 1/7 (14.29%)  1 2/6 (33.33%)  2
Abdominal pain * 1  3/7 (42.86%)  7 0/6 (0.00%)  0 0/4 (0.00%)  0 2/7 (28.57%)  2 0/6 (0.00%)  0
Constipation * 1  2/7 (28.57%)  5 1/6 (16.67%)  2 1/4 (25.00%)  1 1/7 (14.29%)  1 0/6 (0.00%)  0
Stomatitis * 1  2/7 (28.57%)  3 0/6 (0.00%)  0 1/4 (25.00%)  2 1/7 (14.29%)  1 1/6 (16.67%)  1
Gastrooesophageal reflux disease * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 1/4 (25.00%)  1 1/7 (14.29%)  1 0/6 (0.00%)  0
Dry mouth * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Toothache * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Abdominal discomfort * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Abdominal distension * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain lower * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain upper * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Anal incontinence * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Gastritis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Glossodynia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Proctalgia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Retching * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Tongue coated * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
General disorders           
Fatigue * 1  2/7 (28.57%)  2 3/6 (50.00%)  5 0/4 (0.00%)  0 3/7 (42.86%)  3 2/6 (33.33%)  2
Chills * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Non-cardiac chest pain * 1  0/7 (0.00%)  0 1/6 (16.67%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Secretion discharge * 1  1/7 (14.29%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Chest pain * 1  1/7 (14.29%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Early satiety * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Mucosal inflammation * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Oedema peripheral * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0
Influenza like illness * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Malaise * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders           
Hepatic steatosis * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations           
Urinary tract infection * 1  2/7 (28.57%)  6 1/6 (16.67%)  3 2/4 (50.00%)  4 0/7 (0.00%)  0 1/6 (16.67%)  1
Upper respiratory tract infection * 1  1/7 (14.29%)  2 2/6 (33.33%)  2 1/4 (25.00%)  1 2/7 (28.57%)  2 0/6 (0.00%)  0
Conjunctivitis * 1  3/7 (42.86%)  4 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Skin infection * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Pharyngitis * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Gastroenteritis viral * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Oral candidiasis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Paronychia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Pneumonia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Pyuria * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Rhinitis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Viral infection * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications           
Fall * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Corneal abrasion * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Procedural pain * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Investigations           
Neutrophil count decreased * 1  5/7 (71.43%)  15 1/6 (16.67%)  5 2/4 (50.00%)  16 2/7 (28.57%)  7 0/6 (0.00%)  0
Alanine aminotransferase increased * 1  1/7 (14.29%)  4 0/6 (0.00%)  0 1/4 (25.00%)  2 1/7 (14.29%)  1 1/6 (16.67%)  2
Lymphocyte count decreased * 1  3/7 (42.86%)  8 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Transaminases increased * 1  4/7 (57.14%)  8 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Blood alkaline phosphatase increased * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 1/4 (25.00%)  1 2/7 (28.57%)  3 1/6 (16.67%)  1
Platelet count decreased * 1  0/7 (0.00%)  0 2/6 (33.33%)  4 1/4 (25.00%)  3 0/7 (0.00%)  0 0/6 (0.00%)  0
White blood cell count decreased * 1  1/7 (14.29%)  3 1/6 (16.67%)  3 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Blood lactate dehydrogenase increased * 1  2/7 (28.57%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Weight decreased * 1  0/7 (0.00%)  0 1/6 (16.67%)  2 0/4 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0
Aspartate aminotransferase increased * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 1/7 (14.29%)  1 1/6 (16.67%)  1
Blood creatinine increased * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Electrocardiogram QT prolonged * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  2 0/7 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders           
Hyperglycaemia * 1  4/7 (57.14%)  23 1/6 (16.67%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Decreased appetite * 1  3/7 (42.86%)  4 2/6 (33.33%)  2 2/4 (50.00%)  2 2/7 (28.57%)  2 1/6 (16.67%)  1
Hyponatraemia * 1  3/7 (42.86%)  4 1/6 (16.67%)  1 0/4 (0.00%)  0 2/7 (28.57%)  3 1/6 (16.67%)  1
Hypocalcaemia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Dehydration * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Hyperkalaemia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hyperphosphataemia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Hypoalbuminaemia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Hypokalaemia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Hypophosphataemia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Malnutrition * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Muscle spasms * 1  3/7 (42.86%)  5 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Back pain * 1  2/7 (28.57%)  3 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Myalgia * 1  2/7 (28.57%)  2 1/6 (16.67%)  1 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Neck pain * 1  2/7 (28.57%)  2 1/6 (16.67%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Musculoskeletal pain * 1  2/7 (28.57%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Arthralgia * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Groin pain * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Pain in extremity * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders           
Headache * 1  5/7 (71.43%)  6 1/6 (16.67%)  1 1/4 (25.00%)  1 2/7 (28.57%)  2 1/6 (16.67%)  1
Dizziness * 1  2/7 (28.57%)  3 0/6 (0.00%)  0 1/4 (25.00%)  2 1/7 (14.29%)  1 2/6 (33.33%)  2
Dysgeusia * 1  3/7 (42.86%)  3 1/6 (16.67%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1 2/6 (33.33%)  2
Altered state of consciousness * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Muscle spasticity * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Neuropathy peripheral * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Presyncope * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders           
Insomnia * 1  3/7 (42.86%)  3 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders           
Proteinuria * 1  2/7 (28.57%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Dysuria * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Glycosuria * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Haematuria * 1  1/7 (14.29%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Acute kidney injury * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Micturition urgency * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Pollakiuria * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Renal failure * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough * 1  2/7 (28.57%)  5 1/6 (16.67%)  1 2/4 (50.00%)  2 2/7 (28.57%)  2 2/6 (33.33%)  2
Dyspnoea * 1  3/7 (42.86%)  3 0/6 (0.00%)  0 2/4 (50.00%)  3 0/7 (0.00%)  0 3/6 (50.00%)  3
Pulmonary embolism * 1  1/7 (14.29%)  2 1/6 (16.67%)  1 1/4 (25.00%)  1 1/7 (14.29%)  1 0/6 (0.00%)  0
Dyspnoea exertional * 1  1/7 (14.29%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Epistaxis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0
Nasal congestion * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Pneumothorax * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Rhinorrhoea * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 2/4 (50.00%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0
Dysphonia * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Haemoptysis * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Nasal dryness * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Oropharyngeal pain * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Paranasal sinus discomfort * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Pleural effusion * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Pleuritic pain * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Pneumonitis * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Sinus pain * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Wheezing * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash * 1  3/7 (42.86%)  5 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Dry skin * 1  2/7 (28.57%)  2 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Nail disorder * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1
Hyperhidrosis * 1  0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Night sweats * 1  1/7 (14.29%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Pruritus * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Dermatitis * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Erythema * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Scab * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Skin ulcer * 1  0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1
Xeroderma * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders           
Hypertension * 1  2/7 (28.57%)  4 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Deep vein thrombosis * 1  1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment

A limitation of the trial is small numbers of subjects, since only the Phase 1/Part 1 part of the trial was conducted.

A lack of a control group, blinding and randomization also limits the utility of the information, so it is difficult to determine if there is any change in safety or tolerability of the combination of G1T38 + osimertinib from that of osimertinib alone or if there was any selection bias introduced.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Info.
Organization: G1 Therapeutics, Inc.
Phone: 919-213-9835
EMail: clinicalinfo@g1therapeutics.com
Layout table for additonal information
Responsible Party: G1 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03455829    
Other Study ID Numbers: G1T38-03
2017-004315-39 ( EudraCT Number )
First Submitted: February 28, 2018
First Posted: March 7, 2018
Results First Submitted: December 13, 2022
Results First Posted: May 1, 2023
Last Update Posted: May 6, 2023