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Evaluation of AP-002 in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143789
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Altum Pharmaceuticals INC

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE September 27, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Safety Assessment [ Time Frame: Through study completion/ up to 18 months ]
    Number of participants with treatment-related adverse events (safety and tolerability) as assessed by CTCAE v4.0
  • Dose Assessment [ Time Frame: Up to 6 months ]
    Define the recommended phase 2 dose
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2019)
Primary [ Time Frame: Through study completion/ up to 18 months ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Efficacy Assessment [ Time Frame: Through study completion/ up to 18 months ]
    Estimation of anti-tumor activity per RESIST v1.1
  • Efficacy Assessment [ Time Frame: Through study completion/ up to 18 months ]
    For patients with bone metastases, the time to new bone metastasis, progression of bone metastases, or other skeletal related events
  • Pharmacokinetic Assessment [ Time Frame: Through study completion/ up to 18 months ]
    Estimation of pharmacokinetic profile by evaluating maximum plasma concentration [Cmax]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2019)
Secondary [ Time Frame: Through study completion/ up to 18 months ]
Estimation of anti-tumor activity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of AP-002 in Patients With Solid Tumors
Official Title  ICMJE A Phase 1/2 Dose Escalation Study of AP-002 In Patients With Advanced or Recurrent Solid Tumors
Brief Summary The purpose of this trial is to define an effective and safe dose of AP-002 in advanced or recurrent solid tumors for which there are no standard therapies to use in subsequent studies in advanced or recurrent breast, non-small cell lung cancer (NSCLC) or prostate cancers.
Detailed Description

The Phase 1 portion of this study will determine the Pharmacodynamically Active Dose (PAD) of AP-002 in humans, defined as the dose at which the plasma concentration of AP-002, as measured by Ga, is 300-500 ng/mL and which is at or below the Maximum Tolerated Dose (MTD), to use in the clinical setting of advanced or recurrent solid tumors. This will be followed by a Phase 2 expanded cohort treated at the PAD, to estimate the efficacy of AP-002 in patients with advanced or recurrent breast cancer, NSCLC and prostate cancer.

Patients will receive AP-002 orally, once daily for 14 days of a 21 day cycle.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:

Review of safety and pharmacokinetic (PK) parameters by the Clinical Trial Review Committee (CTRC) at the completion of each dose level in the Phase 1 will determine if escalation to the next dose level may occur.

Anticipated Dose Levels in the Phase 1 Portion of the Study Cohort Anticipated Dose Anticipated Sample Size Level 1 8 mg QD PO × 14 days* (1 patient) Level 2 16 mg QD PO × 14 day* (1 patient) Level 3 32 mg QD PO × 14 days* (1 patient) Level 4 64 mg QD PO × 14 days* (1 patient) Level 5 84 mg QD PO × 14 days* (3 patients) Level 6 108 mg QD PO × 14 days* (3 patients) Level 7 140 mg QD PO × 14 days* (3 patients) Level 8 180 mg QD PO × 14 days* (3 patients)

* Note: 21-day schedule with 2 weeks on, one week off. The actual sample size will be guided by the CRM; sample size may be larger for dose levels that require expansion. Interim meetings may occur when relevant new data becomes available between scheduled CTRC meetings

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: AP-002
Dose escalation
Other Name: no other names
Study Arms  ICMJE Experimental: Tablets to be taken orally daily for 14 of 21 day cycle
AP-002 (4 mg and 20 mg tablets) to be taken orally daily for 14 days
Intervention: Drug: AP-002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2019)
61
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Phase 1: Patients with advanced or recurrent solid tumors with target (± non-target) or with only non-target disease, for which there is no standard therapy available Phase 2: Patients with advanced or recurrent breast cancer, NSCLC, or prostate cancer with target (± non-target) or with only non-target disease for which there is no standard therapy available
  2. Patients with bone metastases but without target disease are eligible
  3. Patients with bone metastases must have at least one bone lesion that has not received radiation therapy within 6 weeks prior to Cycle 1 Day 1
  4. Patients must discontinue bisphosphonate and/or denosumab treatment.
  5. Age ≥ 18 years
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  7. O2 saturation ≥ 92% on room air per pulse oximetry
  8. Exhaled nitrous oxide ≤ 50 parts per billion (ppb)
  9. Adequate hematologic, hepatic and renal function defined as:

    1. Hemoglobin ≥ 9 g/dL
    2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    3. Platelet count ≥ 75 × 109/L
    4. Total bilirubin ≤ 2 × upper limit of normal (ULN). Patients with an established diagnosis of Gilberts syndrome with an unconjugated bilirubin ≤ 2 mg/dL and conjugated bilirubin within normal limits (WNL) are eligible.
    5. Serum electrolytes WNL
    6. Transaminases ≤ 3 × ULN
    7. Prothrombin time (PT)/international normalized ratio (INR), thromboplastin time (PTT), or activated PTT (aPTT) ≤ 1.5 × ULN. For patients on therapeutic coumadin, PT (INR) ≤ 2.5 × ULN is acceptable; for patients on therapeutic heparin, PTT (or aPTT) ≤ 2.5 × ULN
    8. Corrected creatinine clearance ≥ 40 mL/minute, based on the Cockcroft-Gault equation
  10. Patient must have discontinued prior antineoplastic therapy at least 21 days prior to Cycle 1 Day 1 and have recovered or stabilized from any prior AEs related to the prior therapy
  11. Provision of signed and dated informed consent form
  12. Serum 25-hydroxyvitamin D ≥ 30 ng/mL by investigative site laboratory at screening

Exclusion Criteria:

  1. Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease
  2. Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening
  3. Receiving dialysis for renal failure
  4. Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  5. Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed
  6. Patients with QT interval of ≥ 480 msec on ECG
  7. Patients with Paget's disease of bone
  8. Patients of childbearing potential unwilling to abstain from sexual intercourse, or employ effective barrier methods of contraception during participation in this trial
  9. Pregnancy or lactation. A negative pregnancy test will be required for women of childbearing potential prior to study enrollment and will be repeated throughout the study. Women of childbearing potential will be defined as women who have not had natural or pharmacologic menopause, nor surgical sterilization.
  10. Patients unwilling or unable to take oral medication, requiring a nasogastric or gastrostomy tube, or unwilling to adhere to the treatment regimen and fasting requirements
  11. Patients unwilling to comply with all study procedures or who are unavailable for the duration of the study
  12. Known allergies to any components of the AP-002 Drug Product
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dawn East, BSN,RN 9544330329 deast@altumpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04143789
Other Study ID Numbers  ICMJE ALT-002-SRE-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Diaries will be left at site and used as source documents
Responsible Party Altum Pharmaceuticals INC
Study Sponsor  ICMJE Altum Pharmaceuticals INC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Angela Ogden, MD Altum Pharmaceuticals
PRS Account Altum Pharmaceuticals INC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP