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Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients. (PANTAX-Ib)

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ClinicalTrials.gov Identifier: NCT04652206
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
Alcedis GmbH
Information provided by (Responsible Party):
Scandion Oncology A/S

Brief Summary:
An open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objectives are to establish the safety profile and the MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. The starting dose of SCO-101 is 150 mg and the dose may be increased to a maximum of 350 mg.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Inoperable Disease Localized Pancreatic Adenocarcinoma Drug: SCO-101 Drug: Gemcitabine Drug: Nab paclitaxel Phase 1 Phase 2

Detailed Description:
The study is an open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objective is to establish the safety, tolerability and MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. Secondary objectives are efficacy and to establish PK parameters of SCO-101. The target indication is patients with inoperal pancreatic cancer who are to be treated with gemcitabine and nab-paclitaxel. The study is designed as a standard 3+3 dose escalation study with increasing doses of SCO-101 and a fixed dose (standard regimen) of gemcitabine and nab-paclitaxel. An interim report will be prepared once the last patient in the MTD cohort has completed one treatment cycle. Patients will continue treatment until disease progression to evaluate secondary objectives. One treatment Cycle is 28 days. The starting dose of SCO-101 is 150 mg 6 daily dosing in a bi-weekly schedule) and may be increased to a maximum of 350 mg (5 cohorts with 50 mg increments). A total of up to 18 patients are anticipated if dose escalation to the 5th cohort. Gemcitabine and nab-paclitaxel is administered according to local standard recommendations once weekly for three weeks followed by one weeks treatment holiday (dosing on day 6, day 13 and day 20). Patients may continue treatment until treatment progression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Standard 3+3 dose escalation design to determine the Maximum Tolerated dose (MTD) of SCO-101 when administered in combination with gemcitabine and nab-paclitaxel, in patients with inoperable pancreatic cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase Ib Prospective Clinical Trial to Investigate Safety, Tolerability and Maximum Tolerated Dose for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : May 15, 2022


Arm Intervention/treatment
Experimental: SCO-101 in combination with gemcitabine and nab-paclitaxel

Patients receive escalating doses of SCO-101 in combination with the standard recommended dose of gemcitabine and nab-paclitaxel according to local clinical practice. Gemcintabine and nab-paclitaxel is the recommended treatment for the patient group.

Starting dose of SCO-101 is 150 mg. Maximum dose tested is 350 mg. The dose is increased with 50 mg increments between each cohort.

Drug: SCO-101
Oral tablets with a strength of 50 mg or 150 mg according to dose level (cohort). Administered for 6 consequtive days in a bi-weekly schedule in each treatment cycle. Treatment until disease progression.

Drug: Gemcitabine
Used according to marketing authorisation

Drug: Nab paclitaxel
Used according to marketing authorisation




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Through study completion, assessed up to 100 months ]
    Safety and tolerability by assessing the number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until four weeks after end of treatment to evaluate safety of SCO-101 in combination with gemcitabine and nab-paclitaxel determined according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE v.5.0).

  2. Maximum Tolerated Dose [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To determine the Maximum Tolerated Dose (MTD) of SCO-101 in combination with gemcitabine and nab-Paclitaxel by assessment of Dose Limiting Toxicities (DLT) to SCO-101.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months. ]
    defined as CR and PR using the RECIST v. 1.1

  2. Clinical Benefit Rate (CBR) [ Time Frame: From benefit (CR, PR or SD > 16 weeks) to progression, assessed up to 100 months ]
    defined as the number of patients obtaining CR, PR, or SD > 16 weeks according to RECIST v.1.1.

  3. Progression Free Survival (PFS) [ Time Frame: From first dosing to progression, assessed up to 100 months ]
    defined as time in months from the date of first study treatment with SCO-101 to the date of disease progression or death from any cause, whichever comes first.

  4. Overall Survival [ Time Frame: through study completion, assessed up to 100 months ]
    defined as time in months from the date of first study treatment to the date of death

  5. Pharmacokinetic profile [ Time Frame: during the first 14 treatment days in the first treatment cycle. ]
    Pharmacokinetic profile of SCO-101 alone and in combination with gemcitabine and nab-paclitaxel


Other Outcome Measures:
  1. Novel predictive biomarker feasibility [ Time Frame: assessed from first administration to end of treatment, assessed up to 100 months. ]
    assessment of biomarkers from blood and tumor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Ability to understand and willingness to provide written informed consent before any trial-related activities.

    2. Age 18 years or older.

    3. Histologically verified pancreatic adenocarcinoma.

    4. Inoperable localized, locally advanced or metastatic pancreatic cancer, not amenable for curatively intended treatment, in patients who are to be treated with gemcitabine and nab-paclitaxel.

    5. Measurable or non-measurable disease determined by CT scan or MRI, according to RECIST 1.1.

    6. Performance status of ECOG ≤ 2 and expected to tolerate the standard recommended (100%) gemcitabine and nab-paclitaxel dose.

    7. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy or treatment with cytotoxic or biologic agents.

    8. ≥ 2 weeks must have elapsed since any prior surgery or radiotherapy

    9. Adequate conditions as evidenced by the following clinical laboratory values:

    • Absolute neutrophils count (ANC) ≥ 1.5 x 10^9/L
    • Hemoglobin is at least 6,0 mmol/L
    • Platelets ≥ 100 x 10^9/L
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
    • Total serum bilirubin ≤ 1.0 ULN
    • Alkaline phosphatase ≤ 2.5 x ULN*
    • Creatinine ≤ 1.5 ULN
    • eGFR within normal limits.
    • Adequate blood clothing function as defined by the International Normalized Ratio (INR) ≤ 1.2.

      10. Life expectancy longer than 3 months.

      11. Sexually active males and females of child-producing potential must use highly effective contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) for the study duration and at least 6 months after the last dose of study drug

      12. Signed informed consent.

Exclusion Criteria:

  • 1. Concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.

    2. Previous surgeries with resection of the complete stomach or greater part of small intestines (excluding the duodenum), whereby absorption of SCO-101 may be affected. Treatment with Creon or similar is allowed.

    3. Difficulty in swallowing tablets.

    4. CNS metastases requiring steroids.

    5. Treatment with antibiotics for infections or with clinical symptoms of active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.

    6. Known HIV positivity.

    7. Known active hepatitis B or C.

    8. Clinically significant (i.e. active) cardiovascular disease:

    • Stroke, Transient ischemic attack (TIA) or myocardial infarction within ≤ 6 months prior to day 1
    • Unstable angina or NYHA Grade II or greater congestive heart failure (CHF)
    • Serious cardiac arrhythmia requiring medication

      9. Mental status, symptomatic epilepsy or other CNS disease where the investigator assess the patient not fit for the clinical study.

      10. Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results. Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcemia or previous organ transplants. Participation in another clinical trial with experimental medication within 30 days prior to registration.

      11. Known hypersensitivity to gemcitabine and/or nab-paclitaxel

      12. Pregnant women or women who are breastfeeding

      13. Prior or present neuropathy > grade I (NCI-CTCAE v.5.0)

      14. Curatively intended treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652206


Contacts
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Contact: Peter M Vestlev, MD +4522779696 pmv@scandiononcology.com

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Morten Ladekarl, Prof., DMSc       morten.ladekarl@rn.dk   
Principal Investigator: Morten Ladekarl, Prof., DMSc         
Sponsors and Collaborators
Scandion Oncology A/S
Alcedis GmbH
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Responsible Party: Scandion Oncology A/S
ClinicalTrials.gov Identifier: NCT04652206    
Other Study ID Numbers: SCO101-002
2020-002627-11 ( EudraCT Number )
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scandion Oncology A/S:
pancreatic
cancer
non-resectable
inoperable
pancreatic adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs