Lung-MAP S1400K: c-MET Positive

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT03574753
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Actual Duration (Months): 40.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA.

S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC V7	Drug: ABBV-399	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
• Actual Study Start Date: Mar 16, 2018
• Actual Primary Completion Date: Dec 21, 2019
• Actual Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: ABBV-399 C-MET overexpression is seen in 30% of patients with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.

Drug: ABBV-399; ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA) [11 months]

   The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Secondary Outcome Measures

1. Investigator-assessed Progression-free Survival) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA). [up to 3 years post sub-study registration]

   Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause.

2. Overall Survival (OS) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA). [up to 3 years post sub-study registration]

   Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause

3. Overall Response Rate (ORR) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA). [Up to 3 years]

   The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

4. Investigator-assessed Progression-free Survival (IA-PFS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA) [Up to 3 years post sub-study registration]

   Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause

5. Overall Survival (OS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA) [Up to 3 years post sub-study registration]

   Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.

6. Duration of Response (DoR) [Up to 3 years post sub-study registration]

   Duration from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response.

7. Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [Duration of treatment and follow up until death or 3 years post sub-registration]

   Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria

1. Patients must have been assigned to S1400I.

2. Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.

3. Patients must not have an active, known, or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

5.2 Sub-Study Specific Clinical/Laboratory Criteria

1. Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations.

2. Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses <= 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.

3. Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Patients with a positive hepatitis C antibody with a negative viral load are allowed. [This criterion replaces common eligibility criteria in Section 5.3m.]

4. Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). [This criterion replaces common eligibility criteria in Section 5.3n.]

5. Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.

6. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.

7. Patients must have a Lipase, Amylase, TSH with reflex Free T3/T4 performed within 7 days prior to sub-study registration. Additional timepoints are noted in Section 9.0, Study Calendar. [Note: For the Canadian sites, testing for lipase only is acceptable.]

8. Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia (see Section 18.1b).

9. Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an EKG and echocardiogram performed to evaluate cardiac function as clinically indicated.

10. Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, CPK, troponin, and echocardiogram.

11. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D

Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). NOTE:

Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Southwest Oncology Group

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 21, 2020
• Informed Consent Form - Oct 21, 2020

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT03574753
• Other Study ID Numbers: S1400K
• First Posted: Jul 2, 2018
• Last Update Posted: Oct 18, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	28 participants were enrolled, but 5 were ineligible. Thus 23 participants were eligible.

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Period Title: Overall Study
STARTED	23
COMPLETED	0
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Overall Participants	23
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	65.3
Sex: Female, Male (Count of Participants)
Female	10 43.5%
Male	13 56.5%
Race/Ethnicity, Customized (Count of Participants)
White	21 91.3%
Asian	2 8.7%
Hispanic	0 0%
Number of lines of prior therapy for stage IV SCC (Count of Participants)
0	7 30.4%
1	7 30.4%
2	5 21.7%
3	3 13%
4	1 4.3%
ECOG performance status (Count of Participants)
0	5 21.7%
1	18 78.3%
Weight loss in the last 6 months (Count of Participants)
<5%	17 73.9%
5%-<10%	3 13%
10%-<20%	3 13%
Smoking status (Count of Participants)
Current	7 30.4%
Former	15 65.2%
Never	1 4.3%
Prior anti-programmed death-ligand (PD-L1) therapy (Count of Participants)
Yes	12 52.2%
No	11 47.8%
Brain metastases at baseline (Count of Participants)
Yes	2 8.7%
No	21 91.3%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Description	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Time Frame	11 months

Outcome Measure Data

Analysis Population Description

All eligible participants

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	23
Number (95% Confidence Interval) [percentage of participants]	9 39.1%

2. Secondary Outcome

Title	Investigator-assessed Progression-free Survival) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Description	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause.
Time Frame	up to 3 years post sub-study registration

Outcome Measure Data

Analysis Population Description

Eligible participants who had been on immunotherapy and relapsed

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	12
Median (95% Confidence Interval) [months]	1.6

3. Secondary Outcome

Title	Overall Survival (OS) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Description	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause
Time Frame	up to 3 years post sub-study registration

Outcome Measure Data

Analysis Population Description

Eligible participants who had been on immunotherapy and relapsed

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	12
Median (95% Confidence Interval) [months]	4.8

4. Secondary Outcome

Title	Overall Response Rate (ORR) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Description	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Eligible participants who had been on immunotherapy and relapsed

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	12
Number (95% Confidence Interval) [percentage of participants]	0 0%

5. Secondary Outcome

Title	Investigator-assessed Progression-free Survival (IA-PFS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Description	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause
Time Frame	Up to 3 years post sub-study registration

Outcome Measure Data

Analysis Population Description

Eligible participants

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	23
Median (95% Confidence Interval) [months]	2.4

6. Secondary Outcome

Title	Overall Survival (OS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Description	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Time Frame	Up to 3 years post sub-study registration

Outcome Measure Data

Analysis Population Description

Eligible participants

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	23
Median (95% Confidence Interval) [months]	5.6

7. Secondary Outcome

Title	Duration of Response (DoR)
Description	Duration from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response.
Time Frame	Up to 3 years post sub-study registration

Outcome Measure Data

Analysis Population Description

Eligible participants who achieved complete or partial response.

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
Measure Participants	2
Mean (Full Range) [months]	8.9

8. Secondary Outcome

Title	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Description	Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Duration of treatment and follow up until death or 3 years post sub-registration

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of protocol treatment.

Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 daysXXX
Measure Participants	23
Anemia	1 4.3%
Anorexia	1 4.3%
Aspartate aminotransferase increased	1 4.3%
Blood bilirubin increased	1 4.3%
Bronchopulmonary hemorrhage	1 4.3%
Cardiac arrest	1 4.3%
Dehydration	1 4.3%
Fatigue	2 8.7%
Febrile neutropenia	1 4.3%
Hypocalcemia	1 4.3%
Hypokalemia	1 4.3%
Hyponatremia	1 4.3%
Hypophosphatemia	2 8.7%
Lymphocyte count decreased	1 4.3%
Nausea	1 4.3%
Neutrophil count decreased	1 4.3%
Peripheral sensory neuropathy	1 4.3%
Pneumonitis	2 8.7%
Respiratory failure	1 4.3%
Urinary tract infection	1 4.3%
Vomiting	1 4.3%

Adverse Events

Time Frame	Duration of treatment and follow up until death or 3 years post sub-study registration
Adverse Event Reporting Description	23 eligible participants that received protocol therapy were assessed for AEs.
Arm/Group Title	ABBV-399
Arm/Group Description	C-MET overexpression is seen in 30% of participants with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition. ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity. ABBV-399: ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
All Cause Mortality
	ABBV-399
	Affected / at Risk (%)	# Events
Total	17/23 (73.9%)
Serious Adverse Events
	ABBV-399
	Affected / at Risk (%)	# Events
Total	10/23 (43.5%)
Blood and lymphatic system disorders
Anemia	1/23 (4.3%)
Febrile neutropenia	1/23 (4.3%)
Cardiac disorders
Atrial fibrillation	1/23 (4.3%)
Cardiac arrest	1/23 (4.3%)
Myocardial infarction	1/23 (4.3%)
Paroxysmal atrial tachycardia	1/23 (4.3%)
Pericardial effusion	1/23 (4.3%)
Gastrointestinal disorders
Abdominal pain	2/23 (8.7%)
Constipation	1/23 (4.3%)
Nausea	1/23 (4.3%)
Stomach pain	1/23 (4.3%)
Upper gastrointestinal hemorrhage	1/23 (4.3%)
Vomiting	1/23 (4.3%)
General disorders
Fatigue	1/23 (4.3%)
Non-cardiac chest pain	1/23 (4.3%)
Pain	1/23 (4.3%)
Infections and infestations
Lung infection	2/23 (8.7%)
Urinary tract infection	1/23 (4.3%)
Injury, poisoning and procedural complications
Spinal fracture	1/23 (4.3%)
Investigations
Aspartate aminotransferase increased	1/23 (4.3%)
Blood bilirubin increased	1/23 (4.3%)
Lymphocyte count decreased	1/23 (4.3%)
Neutrophil count decreased	1/23 (4.3%)
Metabolism and nutrition disorders
Dehydration	1/23 (4.3%)
Hypokalemia	2/23 (8.7%)
Hypophosphatemia	1/23 (4.3%)
Nervous system disorders
Nervous system disorders-Other	1/23 (4.3%)
Syncope	1/23 (4.3%)
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction	1/23 (4.3%)
Bronchopulmonary hemorrhage	1/23 (4.3%)
Dyspnea	2/23 (8.7%)
Hypoxia	2/23 (8.7%)
Pleural effusion	1/23 (4.3%)
Pneumonitis	2/23 (8.7%)
Pulmonary edema	1/23 (4.3%)
Resp, thoracic and mediastinal disorders - Other	1/23 (4.3%)
Respiratory failure	1/23 (4.3%)
Vascular disorders
Hypertension	1/23 (4.3%)
Thromboembolic event	1/23 (4.3%)
Other (Not Including Serious) Adverse Events
	ABBV-399
	Affected / at Risk (%)	# Events
Total	22/23 (95.7%)
Blood and lymphatic system disorders
Anemia	12/23 (52.2%)
Cardiac disorders
Palpitations	1/23 (4.3%)
Sinus bradycardia	1/23 (4.3%)
Sinus tachycardia	2/23 (8.7%)
Ear and labyrinth disorders
Vertigo	2/23 (8.7%)
Endocrine disorders
Endocrine disorders-Other	2/23 (8.7%)
Hyperthyroidism	1/23 (4.3%)
Eye disorders
Blurred vision	1/23 (4.3%)
Cataract	1/23 (4.3%)
Eye disorders-Other	1/23 (4.3%)
Watering eyes	1/23 (4.3%)
Gastrointestinal disorders
Abdominal pain	3/23 (13%)
Constipation	8/23 (34.8%)
Diarrhea	9/23 (39.1%)
Dyspepsia	1/23 (4.3%)
Dysphagia	1/23 (4.3%)
Esophageal pain	1/23 (4.3%)
Esophageal stenosis	1/23 (4.3%)
Esophagitis	1/23 (4.3%)
Gastroesophageal reflux disease	2/23 (8.7%)
Mucositis oral	2/23 (8.7%)
Nausea	8/23 (34.8%)
Oral dysesthesia	1/23 (4.3%)
Oral pain	1/23 (4.3%)
Stomach pain	1/23 (4.3%)
Toothache	1/23 (4.3%)
Vomiting	5/23 (21.7%)
General disorders
Chills	4/23 (17.4%)
Edema limbs	3/23 (13%)
Fatigue	11/23 (47.8%)
Flu like symptoms	1/23 (4.3%)
General disorders and admin site conditions - Other	1/23 (4.3%)
Non-cardiac chest pain	4/23 (17.4%)
Pain	3/23 (13%)
Infections and infestations
Infections and infestations-Other	2/23 (8.7%)
Lung infection	2/23 (8.7%)
Upper respiratory infection	1/23 (4.3%)
Injury, poisoning and procedural complications
Fall	3/23 (13%)
Investigations
Alanine aminotransferase increased	3/23 (13%)
Alkaline phosphatase increased	1/23 (4.3%)
Aspartate aminotransferase increased	2/23 (8.7%)
Blood bilirubin increased	1/23 (4.3%)
Creatinine increased	1/23 (4.3%)
Ejection fraction decreased	1/23 (4.3%)
GGT increased	8/23 (34.8%)
Investigations-Other	4/23 (17.4%)
Lymphocyte count decreased	8/23 (34.8%)
Neutrophil count decreased	1/23 (4.3%)
Platelet count decreased	3/23 (13%)
Weight loss	7/23 (30.4%)
Metabolism and nutrition disorders
Anorexia	7/23 (30.4%)
Dehydration	3/23 (13%)
Hypercalcemia	1/23 (4.3%)
Hyperglycemia	4/23 (17.4%)
Hyperkalemia	1/23 (4.3%)
Hypermagnesemia	2/23 (8.7%)
Hypernatremia	1/23 (4.3%)
Hypertriglyceridemia	2/23 (8.7%)
Hypoalbuminemia	19/23 (82.6%)
Hypocalcemia	6/23 (26.1%)
Hypokalemia	5/23 (21.7%)
Hypomagnesemia	6/23 (26.1%)
Hyponatremia	10/23 (43.5%)
Hypophosphatemia	5/23 (21.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/23 (17.4%)
Back pain	4/23 (17.4%)
Bone pain	2/23 (8.7%)
Generalized muscle weakness	3/23 (13%)
Muscle weakness upper limb	1/23 (4.3%)
Myalgia	2/23 (8.7%)
Pain in extremity	1/23 (4.3%)
Nervous system disorders
Dizziness	5/23 (21.7%)
Dysgeusia	2/23 (8.7%)
Dysphasia	1/23 (4.3%)
Headache	2/23 (8.7%)
Nervous system disorders-Other	1/23 (4.3%)
Peripheral motor neuropathy	1/23 (4.3%)
Peripheral sensory neuropathy	4/23 (17.4%)
Syncope	2/23 (8.7%)
Tremor	1/23 (4.3%)
Psychiatric disorders
Anxiety	2/23 (8.7%)
Depression	1/23 (4.3%)
Insomnia	1/23 (4.3%)
Renal and urinary disorders
Renal and urinary disorders-Other	1/23 (4.3%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/23 (4.3%)
Cough	8/23 (34.8%)
Dyspnea	7/23 (30.4%)
Hoarseness	1/23 (4.3%)
Laryngeal inflammation	1/23 (4.3%)
Nasal congestion	1/23 (4.3%)
Pleural effusion	1/23 (4.3%)
Pneumonitis	2/23 (8.7%)
Productive cough	1/23 (4.3%)
Pulmonary edema	1/23 (4.3%)
Wheezing	1/23 (4.3%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/23 (4.3%)
Skin and subcutaneous tissue disorders - Other	1/23 (4.3%)
Vascular disorders
Hypertension	4/23 (17.4%)
Hypotension	2/23 (8.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.