Trial Outcomes & Findings for Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer (NCT NCT02178436)

Last Updated: 2023-11-07

Results Overview

MTD is defined as the lowest dose for which less than a third of patients experience a dose limiting toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

28 days

Results posted on

2023-11-07

Participant Flow

Accrual time period: 10/31/14 - 02/09/22

2 patients enrolled but did not receive any treatment

Participant milestones

Participant milestones
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	GroupIII: Phase II Group II (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	9	4
Overall Study COMPLETED	9	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 Participants Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	Total n=13 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	—	56 years n=5 Participants	61 years n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	2 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	—	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	—	3 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	—	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	—	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	—	4 participants n=5 Participants	13 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Maximum tolerated dose is only estimated using the Phase 1b samples

Outcome measures

Outcome measures
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib)	80 milligrams	—	—

PRIMARY outcome

Timeframe: Up to 2 years

Population: Group II enrolled no patients because patients refused to undergo the required biopsy.

The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval.

Outcome measures

Outcome measures
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 Participants Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03	1.00 proportion of patients Interval 0.77 to 1.0	—	0.75 proportion of patients Interval 0.36 to 0.94

PRIMARY outcome

Timeframe: Up to 7 months post treatment initiation

Population: Group II enrolled no patients because patients refused to undergo the required biopsy.

Estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed at least one 4-week treatment cycle) using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 Participants Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Overall Survival (Phase II)	5.45 months Interval 4.37 to Median survival (MS) is calculated by using the Kaplan-Meier (KM) curve. The MS is found by seeing where the estimated KM curve intersects with the horizontal line indicating 50% survival (HL-50). The upper 90% confidence value for the MS is found by seeing where the upper confidence band (CB) for the KM estimate intersects with HL-50. For this analysis, the upper CB does not cross 0.5 for the whole time period under study; so it never intersects with HL-50; and thus is not available to report	—	NA months No survival events occurred in this group during the follow-up time. Therefore a median survival and confidence interval are not estimable.

SECONDARY outcome

Timeframe: Day 1 of course 1 (before selinexor administration, 1, 2, 4 and 8 hours after selinexor administration) and days 2, 3 and 8

Population: Pharmacodynamics data was not measured.

Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Group II enrolled no patients because patients refused to undergo the required biopsy. Four patients in Group I were not evaluated for response.

Point and 90% Wilson's confidence intervals will be estimated to describe response rate. If the best observed clinical response was complete response or partial response, we consider that the patient responded.

Outcome measures

Outcome measures
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=5 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 Participants Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Proportion of Patients With a Response	0.40 proportion of patients Interval 0.14 to 0.73	—	0 proportion of patients Interval 0.0 to 0.4

SECONDARY outcome

Timeframe: Up to 2 years

Population: Group II enrolled no patients because patients refused to undergo the required biopsy.

Outcome measures

Outcome measures
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 Participants Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 Participants Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Progression Free Survival (Phase II)	4.60 months Interval 4.37 to Median survival (MS) is calculated by using the Kaplan-Meier (KM) curve. The MS is found by seeing where the estimated KM curve intersects with the horizontal line indicating 50% survival (HL-50). The upper 90% confidence value for the MS is found by seeing where the upper confidence band (CB) for the KM estimate intersects with HL-50. For this analysis, the upper CB does not cross 0.5 for the whole time period under study; so it never intersects with HL-50; and thus is not available to report	—	1.74 months Interval 1.22 to Median survival (MS) is calculated by using the Kaplan-Meier (KM) curve. The MS is found by seeing where the estimated KM curve intersects with the horizontal line indicating 50% survival (HL-50). The upper 90% confidence value for the MS is found by seeing where the upper confidence band (CB) for the KM estimate intersects with HL-50. For this analysis, the upper CB does not cross 0.5 for the whole time period under study; so it never intersects with HL-50; and thus is not available to report

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 2 years

Population: Gene expression data was not measured.

Seven patients in each group will yield a two-sided 90% confidence interval with a distance from the mean change to the limits of 0.75 standard deviation units. A two-sided p-value of 0.10 will be used for all analyses.

Outcome measures

Outcome data not reported

Adverse Events

Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 9 deaths

Group II: Phase II Group I (Gemcitabine, Selinexor)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GroupIII: Phase II Group II (Gemcitabine, Selinexor)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) n=9 participants at risk Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies Nab paclitaxel: Given IV	Group II: Phase II Group I (Gemcitabine, Selinexor) Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies	GroupIII: Phase II Group II (Gemcitabine, Selinexor) n=4 participants at risk Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV Selinexor: Given IV Pharmacological Study: Correlative studies Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Abdominal Pain	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Nervous system disorders Cognitive disturbance	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
General disorders Death NOS	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Nervous system disorders Headache	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Investigations Hyperglycemia	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Gastrointestinal disorders Nausea	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Psychiatric disorders Psychiatric disorders - Other	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Renal and urinary disorders Renal and urinary disorders - Other	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Nervous system disorders Stroke	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Psychiatric disorders Suicidal ideation	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.
Psychiatric disorders Suicide attempt	11.1% 1/9 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	— 0/0 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.	0.00% 0/4 • The adverse events were collected from cycle one day one of study treatment until four weeks follow up visit or thirty days after study treatment was discontinued up to 2 years. No patients were enrolled in Group 2, so the number of patients at risk is 0 for that group.

Other adverse events

Additional Information

Mohammed Najeeb Al Hallak M.D.

Karmanos Cancer Institute

Phone: 313-576-8718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place