Advanced Solid TumorsPhase 1NCT02609230
A Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma
A Phase 1 study testing ONC-201 in people with Advanced Solid Tumors and Multiple Myeloma, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Multiple Myeloma
- What is being tested?
- ONC-201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2015to 26 Mar 2020
- Phase
- Phase 1
- 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
- Solid tumor specific:
- Patients must have a histologically/cytologically confirmed primary solid tumor
- Radiographic or clinical evidence of advanced/metastatic malignant disease that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurable or non-measurable
- Multiple myeloma specific:
- Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment
- Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present), (>=0.2 g excreted in a 24 hour collection sample).
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- Subjects with free light chain only disease are excluded
- All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas ) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list
- Age ≥ 18 years
- ECOG performance status ≤ 1
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to C1D1
- Platelets ≥75,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1
- Hemoglobin >8.0 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1
- Total serum bilirubin <1.5 X upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor
- Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
- Serum or urine pregnancy test (for females of childbearing potential) negative ≤7 days of starting treatment
- Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
- Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.
Who cannot join
- Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted.
- Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
- Pregnancy or breast feeding
- Current active treatment in another clinical study
- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
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- Multiple myeloma specific:
- Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L)
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
- Subjects with serum calcium (corrected for albumin) ≥ 12 mg/dL
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Phase I Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma
This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma.
Read the detailed description
This phase 1 study will determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ONC201, when given as a single agent, to patients with advanced solid tumors or multiple myeloma, in two dose schedules including every 3 weeks and weekly. For the first arm (A), dose escalation will use the following single patient dose-escalation cohorts based on 'Design 4' proposed by Simon and colleagues: 125, 250, 500, and 625 mg. Following completion of Arm A dose escalation, subsequent cohorts will be tested in a minimum of 3 patients. The Arm B dose cohort will consist of dose levels administered once every one week (planned dosing of 250, 375, 500 and 625 mg). Dependent on PK and PD data, or emerging efficacy data, additional dose levels in Arm A or Arm B may be explored.
For Arm A, single patient cohorts will be used until the first instance of DLT or the second instance of grade 2 toxicity. Either occurrence will lead to immediate use of a modified 3+3 design and ~40% dose increments. Arm B will use a 3 + 3 design for all cohorts. It is anticipated that 16 - 48 evaluable patients in the dose escalation and an additional 17 patients in the expansion phase will be enrolled into this study over the course of 2 years. Patients will receive ONC201 in 3-week cycles until disease progression, unacceptable toxicity, or the patient discontinues for any other reason. The maximum duration of treatment will be 12 months unless it is determined that a patient would derive benefit from continued therapy beyond 12 months.
- Conditions
- Advanced Solid Tumors, Multiple Myeloma
- Being tested
- ONC-201
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONC-201Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | For the first arm (A), dose escalation will use the following single patient dose-escalation cohorts based on 'Design 4' proposed by Simon and colleagues: 125, 250, and 500 mg. every 3 weeks. Receives: Drug: ONC-201 |
| B | Experimental | Following completion of Arm A dose escalation, subsequent cohorts will be tested in a minimum of 3 patients, the Arm B dose cohort will consist of dose levels administered every week (planned dosing of 250, 375, 500 and 625 mg). Receives: Drug: ONC-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of ONC201
Measured: At day 21 of Cycle 1 of therapy
Secondary outcomes (1)
Peak Plasma Concentration of ONC201
Measured: 0, 0.5, 2, 4, 6, 24, 48, 72, 168 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start5 Nov 2015
- Primary completionMar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Olszanski, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609230
- Sponsor's protocol ID
- PH-077
- Other IDs
- 15-1009
- Status last verified
- Jun 2021
- First submitted
- 10 Nov 2015
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02609230
- Acronym / sponsor ID
- PH-077
- Conditions
- Advanced Solid Tumors, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma.
Detailed description
This phase 1 study will determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ONC201, when given as a single agent, to patients with advanced solid tumors or multiple myeloma, in two dose schedules including every 3 weeks and weekly. For the first arm (A), dose escalation will use the following single patient dose-escalation cohorts based on 'Design 4' proposed by Simon and colleagues: 125, 250, 500, and 625 mg. Following completion of Arm A dose escalation, subsequent cohorts will be tested in a minimum of 3 patients. The Arm B dose cohort will consist of dose levels administered once every one week (planned dosing of 250, 375, 500 and 625 mg). Dependent on PK and PD data, or emerging efficacy data, additional dose levels in Arm A or Arm B may be explored.
For Arm A, single patient cohorts will be used until the first instance of DLT or the second instance of grade 2 toxicity. Either occurrence will lead to immediate use of a modified 3+3 design and ~40% dose increments. Arm B will use a 3 + 3 design for all cohorts. It is anticipated that 16 - 48 evaluable patients in the dose escalation and an additional 17 patients in the expansion phase will be enrolled into this study over the course of 2 years. Patients will receive ONC201 in 3-week cycles until disease progression, unacceptable toxicity, or the patient discontinues for any other reason. The maximum duration of treatment will be 12 months unless it is determined that a patient would derive benefit from continued therapy beyond 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ONC-201For the first arm (A), dose escalation will use the following single patient dose-escalation cohorts based on 'Design 4' proposed by Simon and colleagues: 125, 250, and 500 mg. every 3 weeks. |
| B | Experimental | Drug: ONC-201Following completion of Arm A dose escalation, subsequent cohorts will be tested in a minimum of 3 patients, the Arm B dose cohort will consist of dose levels administered every week (planned dosing of 250, 375, 500 and 625 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Solid tumor specific:
- Multiple myeloma specific:
- All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas ) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list
- Age ≥ 18 years
- ECOG performance status ≤ 1
Key exclusion criteria (12 listed)
- Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases > 28 days prior to study entry including radiotherapy or surgery. Steroids for the treatment of brain metastasis are not permitted.
- Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
- Pregnancy or breast feeding
- Current active treatment in another clinical study
- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), requiring treatment with IV antibiotic, IV anti-fungal, or anti-viral.
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 |
|---|---|---|
| ONC-201 | Drug | A, B |
Primary outcome
Determine the maximum tolerated dose of ONC201
Time frame: At day 21 of Cycle 1 of therapy
1 secondary outcome
Peak Plasma Concentration of ONC201
Time frame: 0, 0.5, 2, 4, 6, 24, 48, 72, 168 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
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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.
Anthony Olszanski, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONC-201 in people with Advanced Solid Tumors and Multiple Myeloma, run by Fox Chase Cancer Center at 1 site 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: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose of ONC201 (time frame: At day 21 of Cycle 1 of therapy). 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 4 Jun 2021.