Solid TumorPhase 1/2NCT04143789
Evaluation of AP-002 in Patients With Solid Tumors
A Phase 1/2 study testing AP-002 in people with Solid Tumor, run by Altum Pharmaceuticals INC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AP-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Sep 2019to Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with bone metastases but without target disease are eligible
- 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
- Patients must discontinue bisphosphonate and/or denosumab treatment.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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- O2 saturation ≥ 92% on room air per pulse oximetry
- Exhaled nitrous oxide ≤ 50 parts per billion (ppb)
- Adequate hematologic, hepatic and renal function defined as:
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelet count ≥ 75 × 109/L
- 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.
- Serum electrolytes WNL
- Transaminases ≤ 3 × ULN
- 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
- Corrected creatinine clearance ≥ 40 mL/minute, based on the Cockcroft-Gault equation
- 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
- Provision of signed and dated informed consent form
- Serum 25-hydroxyvitamin D ≥ 30 ng/mL by investigative site laboratory at screening
Who cannot join
- Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease
- Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening
- Receiving dialysis for renal failure
- Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed
- Patients with QT interval of ≥ 480 msec on ECG
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- Patients with Paget's disease of bone
- Patients of childbearing potential unwilling to abstain from sexual intercourse, or employ effective barrier methods of contraception during participation in this trial
- 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.
- 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
- Patients unwilling to comply with all study procedures or who are unavailable for the duration of the study
- Known allergies to any components of the AP-002 Drug Product
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
Research Institution
Chicago, Illinois, 60208
- Recruiting
Investigational Site
Houston, Texas, 77030
- Recruiting
Research Site
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/2 Dose Escalation Study of AP-002 In Patients With Advanced or Recurrent Solid Tumors
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- AP-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-002Drug
Also called no other names
Dose escalation
| Study group | Role | What they receive |
|---|---|---|
| Tablets to be taken orally daily for 14 of 21 day cycle | Experimental | AP-002 (4 mg and 20 mg tablets) to be taken orally daily for 14 days Receives: Drug: AP-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
Number of participants with treatment-related adverse events (safety and tolerability) as assessed by CTCAE v4.0
Measured: Through study completion/ up to 18 months
Dose Assessment
Define the recommended phase 2 dose
Measured: Up to 6 months
Secondary outcomes (3)
Efficacy Assessment
Estimation of anti-tumor activity per RESIST v1.1
Measured: Through study completion/ up to 18 months
Efficacy Assessment
For patients with bone metastases, the time to new bone metastasis, progression of bone metastases, or other skeletal related events
Measured: Through study completion/ up to 18 months
Pharmacokinetic Assessment
Estimation of pharmacokinetic profile by evaluating maximum plasma concentration [Cmax]
Measured: Through study completion/ up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start27 Sep 2019
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- 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)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altum Pharmaceuticals INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela Ogden, MD, Study chair, Altum Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143789
- Sponsor's protocol ID
- ALT-002-SRE-01
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Diaries will be left at site and used as source documents
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation Study of AP-002 In Patients With Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT04143789
- Acronym / sponsor ID
- ALT-002-SRE-01
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Altum Pharmaceuticals INCIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Tablets to be taken orally daily for 14 of 21 day cycle | Experimental | Drug: AP-002AP-002 (4 mg and 20 mg tablets) to be taken orally daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
- Patients with bone metastases but without target disease are eligible
- 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
- Patients must discontinue bisphosphonate and/or denosumab treatment.
- Age ≥ 18 years
Key exclusion criteria (12 listed)
- Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease
- Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening
- Receiving dialysis for renal failure
- Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-002Also: no other namesDose escalation | Drug | Tablets to be taken orally daily for 14 of 21 day cycle |
Primary outcome
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
3 secondary outcomes
Efficacy Assessment
Time frame: Through study completion/ up to 18 months
Efficacy Assessment
Time frame: Through study completion/ up to 18 months
Pharmacokinetic Assessment
Time frame: Through study completion/ up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No. Diaries will be left at site and used as source documents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Ogden, MD study chair
Altum Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AP-002 in people with Solid Tumor, run by Altum Pharmaceuticals INC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn East, BSN,RN (9544330329, deast@altumpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: Through study completion/ up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.