Trial Outcomes & Findings for Tarlox and Sotorasib in Patients With KRAS G12C Mutations (NCT NCT05313009)
NCT ID: NCT05313009
Last Updated: 2025-12-16
Results Overview
(OR = CR+PR) measured by CT and assessed per RECIST 1.1. Complete response (CR) and partial response (PR) require confirmatory CT
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
There is no defined time frame for response assessment in the protocol. Presumably, patients are followed for response until the they stop taking study drug and/or have disease progression. The latest an assessment occurred for a patient was 40 weeks.
Results posted on
2025-12-16
Participant Flow
All participants in Stage 1 received the same dose of Tarloxotinib (150 mg/m² weekly) following initial safety evaluation. Therefore, participants were combined into a single arm/group in the Participant Flow table to reflect this uniform dosing. All 5 patients were enrolled only into the starting dose, Dose Level 0 (full dose: 960 mg Sot; 150 mg/m2 Tarlox).
Participant milestones
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs - Participants receive the same dose at start of safety lead-in and if too much toxicity, then the participant steps down to the next lowest dose.
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs - Participants receive the same dose at start of safety lead-in and if too much toxicity, then the participant steps down to the next lowest dose.
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Tarlox and Sotorasib in Patients With KRAS G12C Mutations
Baseline characteristics by cohort
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, Depending on Number of DLs Explored)
n=5 Participants
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=6 Participants
|
—
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=6 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=6 Participants
|
—
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: There is no defined time frame for response assessment in the protocol. Presumably, patients are followed for response until the they stop taking study drug and/or have disease progression. The latest an assessment occurred for a patient was 40 weeks.Population: Subjects only enrolled in safety-lead in there is no data for efficacy portion. Study was prematurely terminated due to study drug being withdrawn by manufacturer. No patient had an Objective Response to therapy.
(OR = CR+PR) measured by CT and assessed per RECIST 1.1. Complete response (CR) and partial response (PR) require confirmatory CT
Outcome measures
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
n=1 Participants
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Objective Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At least 4 weeks.Population: Study was prematurely terminated due to study drug being withdrawn by manufacturer. Patients can have a response at one time point but at the next time point data was not collected to confirm which is necessary to measure duration of response.
measured from the date of first response (CR or PR) to date of disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 18 months.Population: Study was prematurely terminated due to study drug being withdrawn by manufacturer. Patients can have a response at one time point but at the next time point it was not confirmed which is necessary to measure disease control rate.
(DCR) based on patient who had CR or PR or Stable disease (SD)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: A minimum timeframe of 8 weeks is required for a BOR of SD.Population: No participants could be observed for BOR. Study was prematurely terminated due to study drug being withdrawn by manufacturer.
(BOR) determined from a sequence of responses assessed. Two objective status determinations of CR before progression are required for a BOR of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a BOR of PR.
Outcome measures
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Best Overall Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of first study drug dose to the date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 100 months.Population: There were no number of events obtained to be observed for PFS. Study was prematurely terminated due to study drug being withdrawn by manufacturer.
(PFS) as measured from the date of first study drug dose to the date of the first objective documentation of radiographic disease progression or death due to any cause.
Outcome measures
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Progression Free Survival
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Follow-up for survival continues until 6 months after the last patient on-study visit.Population: One participant was not evaluable due to death before receiving first dose of study drug. Study was terminated early due to study drug being withdrawn by manufacturer.
(OS) as measured from the date of first study drug dose to the date of death by any cause.
Outcome measures
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
n=4 Participants
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Overall Survival
|
0.75 years
Interval 0.0 to 0.75
|
—
|
Adverse Events
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
STAGE 2: EFFICACY (n=12)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
n=4 participants at risk
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
Other adverse events
| Measure |
STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)
n=4 participants at risk
SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
STAGE 2: EFFICACY (n=12)
EFFICACY (n=12)
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly
Sotorasib and Tarloxotinib: Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Cardiac disorders
Prolonged QTc interval
|
50.0%
2/4 • Number of events 2 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Nervous system disorders
Facial muscle weakness
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Infections and infestations
Otitis media
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Immune system disorders
Allergic reaction
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Cardiac disorders
Cardiac chest pain
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease (GERD)
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Skin and subcutaneous tissue disorders
Limb edema
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
|
Skin and subcutaneous tissue disorders
Umbilical hernia
|
25.0%
1/4 • Number of events 1 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
—
0/0 • Up to 22 months
No participants were enrolled in Stage 2 of the study. Study was prematurely withdrawn due to study drug being withdrawn by manufacturer.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place