A Phase 1/2 interventional study of gemcitabine hydrochloride and Selinexor in Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas and Stage IV Pancreatic Cancer, sponsored by Mohammed Najeeb Al Hallak. Completed at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Mohammed Najeeb Al Hallak · Phase 1/2, Interventional, and Treatment
This partially randomized phase Ib/II trial studies the side effects and best dose of selinexor when given together with gemcitabine and nab-paclitaxel, and to see how well they work in treating patients with pancreatic cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as selinexor, gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Primary Objectives:
Secondary Objectives:
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →This is the only study on the registry with Mohammed Najeeb Al Hallak as lead sponsor.
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Exclusion Criteria:
Unstable cardiovascular function:
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.
Drug: gemcitabine hydrochloride · Drug: Selinexor · Other: Pharmacological Study · Other: Laboratory Biomarker Analysis · Drug: Nab paclitaxel
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
Drug: gemcitabine hydrochloride · Drug: Selinexor · Other: Pharmacological Study · Other: Laboratory Biomarker Analysis
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.
Drug: gemcitabine hydrochloride · Drug: Selinexor · Other: Pharmacological Study · Other: Laboratory Biomarker Analysis
Given IV
Also known as: dFdC, difluorodeoxycytidine hydrochloride, Gemcitabine HCI, Gemzar
Given IV
Also known as: KPT-330, Xpovio, CRM1 nuclear export inhibitor KPT-330, selective inhibitor of nuclear export KPT-330, SINE KPT-330
Correlative studies
Correlative studies
Given IV
Also known as: ABI 007, Abraxane, Protein-bound Paclitaxel, Nanoparticle Paclitaxel,
Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib)
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.
Time frame: 28 days
Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03
The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval.
Time frame: Up to 2 years
Overall Survival (Phase II)
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.
Time frame: Up to 7 months post treatment initiation
Effects the Study Drug Combination Has on Participants
Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation
Time frame: Day 1 of course 1 (before selinexor administration, 1, 2, 4 and 8 hours after selinexor administration) and days 2, 3 and 8
Proportion of Patients With a 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.
Time frame: Up to 2 years
Progression Free Survival (Phase II)
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. Both progression and death are considered events for this analysis.
Time frame: Up to 2 years
Change in Gene Expression (Including Forkhead Box Protein O, I-kappaB, Cyclin-dependent Kinase Inhibitor 1B, Par4 and Phosphorylated Signal Transducer and Activator of Transcription 3) (Phase II)
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.
Time frame: Baseline to up to 2 years
Accrual time period: 10/31/14 - 02/09/22
| Milestone | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Started | 9 | 0 | 4 |
| Completed | 9 | 0 | 4 |
| Not completed | 0 | 0 | 0 |
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.
| milligrams | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-stabilized Nanoparticle Formulation Combination (Phase Ib) | 80 | — | — |
The reported output is the proportion of patients that had a toxic event along with the associated 90% Wilson's confidence interval.
| proportion of patients | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Proportion of Patients With a Toxic Event, Graded According to NCI CTCAE Version 4.03 | 1.00 (0.77 to 1.00) | — | 0.75 (0.36 to 0.94) |
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.
| months | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Overall Survival (Phase II) | 5.45 (4.37 to NA) | — | NA (NA to NA) |
Pharmacodynamics of selinexor in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation
No measurements were reported for this outcome.
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.
| proportion of patients | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Proportion of Patients With a Response | 0.40 (0.14 to 0.73) | — | 0 (0 to 0.40) |
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. Both progression and death are considered events for this analysis.
| months | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Progression Free Survival (Phase II) | 4.60 (4.37 to NA) | — | 1.74 (1.22 to NA) |
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.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | 9/9 (100%) | 6/9 (66.7%) | 9/9 (100%) |
| Group II: Phase II Group I (Gemcitabine, Selinexor) | — | — | — |
| GroupIII: Phase II Group II (Gemcitabine, Selinexor) | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Event | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| Abdominal PainGastrointestinal disorders | 1/9 | — | 0/4 |
| Cognitive disturbanceNervous system disorders | 1/9 | — | 0/4 |
| Death NOSGeneral disorders | 1/9 | — | 0/4 |
| HeadacheNervous system disorders | 1/9 | — | 0/4 |
| HyperglycemiaInvestigations | 1/9 | — | 0/4 |
| NauseaGastrointestinal disorders | 1/9 | — | 0/4 |
| Psychiatric disorders - OtherPsychiatric disorders | 1/9 | — | 0/4 |
| Renal and urinary disorders - OtherRenal and urinary disorders | 1/9 | — | 0/4 |
| StrokeNervous system disorders | 1/9 | — | 0/4 |
| Suicidal ideationPsychiatric disorders | 1/9 | — | 0/4 |
| Event | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) |
|---|---|---|---|
| FatigueGeneral disorders | 8/9 | — | 0/4 |
| NauseaGastrointestinal disorders | 8/9 | — | 0/4 |
| DiarrheaGastrointestinal disorders | 7/9 | — | 1/4 |
| VomitingGastrointestinal disorders | 7/9 | — | 0/4 |
| Dry skinSkin and subcutaneous tissue disorders | 6/9 | — | 0/4 |
| Peripheral sensory neuropathyNervous system disorders | 5/9 | — | 0/4 |
| AnorexiaGastrointestinal disorders | 4/9 | — | 0/4 |
| DysgeusiaNervous system disorders | 4/9 | — | 0/4 |
| Eye disorders - Other, specifyEye disorders | 4/9 | — | 0/4 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/9 | — | 0/4 |
Group II enrolled no patients because patients refused to undergo the required biopsy.
| Age, Continuous(years) | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Total |
|---|---|---|---|---|
| Median | 68 (61 to 73) | — | 56 (53 to 56.5) | 61 (56 to 72) |
| Sex: Female, Male(Participants) | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Total |
|---|---|---|---|---|
| Female | 4 | — | 2 | 6 |
| Male | 5 | — | 2 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 | 0 |
| Not Hispanic or Latino | 8 | — | 3 | 11 |
| Unknown or Not Reported | 1 | — | 1 | 2 |
| Race (NIH/OMB)(Participants) | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 | 0 |
| Asian | 0 | — | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 | 0 |
| Black or African American | 2 | — | 1 | 3 |
| White | 6 | — | 2 | 8 |
| More than one race | 0 | — | 0 | 0 |
| Unknown or Not Reported | 1 | — | 0 | 1 |
| Region of Enrollment(participants) | Group I: Phase Ib (Gemcitabine, Nab-paclitaxel, Selinexor) | Group II: Phase II Group I (Gemcitabine, Selinexor) | GroupIII: Phase II Group II (Gemcitabine, Selinexor) | Total |
|---|---|---|---|---|
| United States | 9 | — | 4 | 13 |
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