SarcomaPhase 1NCT03002805
CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
A Phase 1 study testing CBT-1® in people with Sarcoma, run by CBA Research at 6 sites in United States.
Trial summary
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- CBT-1®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 46 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Mar 2018to Sep 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
- Age ≥ 18 years
- Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent
- Measurable disease by RECIST 1.1
- ECOG performance status of ≤ 1
- Life expectancy of > 3 months
- Able to swallow pills
Show all 24Show fewer
- Adequate bone marrow and organ function as defined as:
- Hemoglobin > 9 g/dl
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin < 1.5 X ULN
- AST(SGOT)/ALT(SGPT) ≤3 X ULN (including patients with liver metastases)
- Creatinine <1.5 X ULN
- Cardiac ejection fraction >50% (by echocardiogram or MUGA) within 15 days of enrollment
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
- Participants must be willing and able to comply with the study scheduled visits, laboratory tests, and other procedures outlined in the protocol.
- Pre-menopausal women must have a negative pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant, double barrier and/or complete abstinence (non-periodic).
- Washout period prior to Day 1 Cycle 1:
- 3 weeks since last chemotherapy or therapeutic radiation therapy
- 4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter
- 2 weeks since any oral anti-neoplastic or oral investigational agent
- Resolution of treatment-related toxicity to < grade 1; alopecia and cutaneous toxicity are allowed < grade 2
- >1 week since palliative RT
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior exposure to CBT-1
- Previously untreated sarcomas
- Low-grade sarcomas as well as alveolar soft parts sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, gastrointestinal stromal tumor, chordoma
- Participants receiving other investigational agents
- Participants with known uncontrolled brain metastases
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic indwelling drains, history of interstitial pneumonitis or pulmonary fibrosis or psychiatric illness/social situations that would limit compliance with study requirements
- Actively breastfeeding women unless it is interrupted during treatment and at least 6 weeks after treatment discontinuation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Barbara Anderson, RN, 617-643-2427, banderson15@partners.org
Gregory Cote, M.D., Ph.D.
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Research Nursing, 617-632-5204
Katherine Thornton, M.D.
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Sherry Cook, RN, 904-953-3321, cook.sherry1@mayo.edu
Steven Attia, D.O.
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Melissa Burgess, M.D., 412-692-4724, burgessma@upmc.edu
Melissa Burgess, M.D.
- Recruiting
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Victoria Chua-Alcala, 310-552-9999, vchua@sarcomaoncololgy.com
Sant P. Chawla, M.D.
- Recruiting
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Roxanne Moore, 206-606-6425, romoore@seattlecca.org
Lee Cranmer, M.D.
About this study
Official title: A Phase I Trial of CBT-1® in Combination With Doxorubicin in Patients With Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or Less of Doxorubicin
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
- Conditions
- Sarcoma
- Being tested
- CBT-1®
- Keywords
- Phase I, CBT-1®, Doxorubicin, Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-1®Drug
Also called doxorubicin
CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®:
Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of CBT-1® when combined with doxorubicin
Measured: 3 years
Secondary outcomes (3)
Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin
Measured: 3 years
Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin
DCR = Overall Response Rate [ORR = Complete Response + Partial Response] + Stable Disease by RECIST 1.1
Measured: week 12
Overall Response Rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start29 Mar 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CBA Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002805
- Sponsor's protocol ID
- STS-1701
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2016
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
PubMed 31401903
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of CBT-1® in Combination With Doxorubicin in Patients With Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or Less of Doxorubicin
- ClinicalTrials.gov ID
- NCT03002805
- Acronym / sponsor ID
- STS-1701
- Conditions
- Sarcoma
- Keywords
- Phase I, CBT-1®, Doxorubicin, Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- CBA ResearchIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 Dec 2016 (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 evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years
- Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent
- Measurable disease by RECIST 1.1
- ECOG performance status of ≤ 1
- Life expectancy of > 3 months
Key exclusion criteria (7 listed)
- Prior exposure to CBT-1
- Previously untreated sarcomas
- Low-grade sarcomas as well as alveolar soft parts sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, gastrointestinal stromal tumor, chordoma
- Participants receiving other investigational agents
- Participants with known uncontrolled brain metastases
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 |
|---|---|---|
| CBT-1®Also: doxorubicinCBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®: Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed. | Drug | – |
Primary outcome
Maximum tolerated dose of CBT-1® when combined with doxorubicin
Time frame: 3 years
3 secondary outcomes
Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin
Time frame: 3 years
Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin
Time frame: week 12
Overall Response Rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Derived from this study: PubMed 31401903Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT-1® in people with Sarcoma, run by CBA Research at 6 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 24 inclusion and 7 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beth Gudeman (859-266-5757, bethg@cba-1.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of CBT-1® when combined with doxorubicin (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002805, which also lists 1 linked publication.
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 19 Aug 2019.