Advanced Refractory Solid TumorsEarly Phase 1NCT03863145
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
A Early Phase 1 study testing CB-03-10 in people with Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10, run by Cosmo Technologies Ltd at 6 sites in United States.
Trial summary
Subjects will undergo baseline evaluation and an assessment of extent of disease. Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Refractory Solid Tumors, Subjects Considered Likely to Respond to CB-03-10
- What is being tested?
- CB-03-10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jun 2022to 1 Jun 2026
- Phase
- Early 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
- Signed informed consent For Part 1 (Dose Escalation): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable to standard therapy For Part 2 (Dose Expansion): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific tumor subtype as determined by the SRC Age >18 years Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 For Part 1 (Dose Escalation): Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria For Part 2 (Dose Expansion): Measurable disease as per RECIST v1.1 criteria. Adequate renal, hepatic and bone marrow function as defined by Screening labs Negative pregnancy test for females of childbearing potential at the Screening Visit and use of appropriate method of birth control.
- EXCLUSION CRITERIA Pregnant or breastfeeding women Known central nervous system (CNS) metastases or spinal cord compression Known second cancer of other primary origin (excluding Stage I non-melanoma skin cancer and prostate cancer controlled with hormonal therapy) within the prior 5 years Active autoimmune disease Significant cardiac disease Uncontrolled hypertension Major surgery or irradiation within 28 days prior to start of study treatment Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from prior anticancer therapy Requirement for chronic corticosteroids or other immunosuppressant drugs Known infection with hepatitis B or C virus Known infection with HIV and CD4+ T-cell counts < 350 cells/uL Patients with an opportunistic infection within the past 12 months.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of California Irvine Health Chao Family Comprehensive Cancer Center
California City, California, 92868
Farshid Dayyani
- Recruiting
University of Colorado Cancer Center
Colorado Springs, Colorado, 80045
Jennifer Diamond
- Recruiting
Barbara Ann Karmanos Cancer Institute
Michigan Center, Michigan, 48201
Ira Winer
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 208028
Joseph Kim
- Recruiting
Gabrail Cancer Center
Ohio City, Ohio, 44718
Gabrail Nashat
- Recruiting
Tranquil Clinical Research
Texas City, Texas, 77598
John Knecht
About this study
Official title: Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Read more
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Read the detailed description
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
- Being tested
- CB-03-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-03-10Drug
CB-03-10, 100 mg capsule for oral use
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Part 1 (Dose Escalation): 100 mg daily. Receives: Drug: CB-03-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose
Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
Measured: 29 days
Determine the dose-limiting toxicity
Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors
Measured: 28 days
Secondary outcomes (1)
Determine a recommended Phase 2 dose (RP2D) of CB-03-10
Determine a recommended Phase 2 dose (RP2D) of CB-03-10
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start14 Jun 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Advanced Refractory Solid TumorsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Part 1 (Dose Escalation): Subjects with advanced refractory solid tumors Part 2 (Dose Expansion): Defined subject subgroups considered likely to respond to CB-03-10 (eg, relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, triple-negative breast adenocarcinoma) or indications that demonstrated activity in Part 1
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863145
- Sponsor's protocol ID
- CB-03-10/01
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
PubMed 7082756Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
PubMed 21969517Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PubMed 24131140Conroy T, Gavoille C, Samalin E, Ychou M, Ducreux M. The role of the FOLFIRINOX regimen for advanced pancreatic cancer. Curr Oncol Rep. 2013 Apr;15(2):182-9. doi: 10.1007/s11912-012-0290-4.
PubMed 23341367Brower V. New approaches tackle rising pancreatic cancer rates. J Natl Cancer Inst. 2014 Dec 22;106(12):dju417. doi: 10.1093/jnci/dju417. Print 2014 Dec. No abstract available.
PubMed 25535299Schweizer MT, Gulati R, Mostaghel EA, Nelson PS, Montgomery RB, Yu EY, Cheng HH. Docetaxel-related toxicity in metastatic hormone-sensitive and metastatic castration-resistant prostate cancer. Med Oncol. 2016 Jul;33(7):77. doi: 10.1007/s12032-016-0793-1. Epub 2016 Jun 14.
PubMed 27300548Block TS, Murphy TI, Munster PN, Nguyen DP, Lynch FJ. Glucocorticoid receptor expression in 20 solid tumor types using immunohistochemistry assay. Cancer Manag Res. 2017 Mar 6;9:65-72. doi: 10.2147/CMAR.S124475. eCollection 2017.
PubMed 28293120Stringer-Reasor EM, Baker GM, Skor MN, Kocherginsky M, Lengyel E, Fleming GF, Conzen SD. Glucocorticoid receptor activation inhibits chemotherapy-induced cell death in high-grade serous ovarian carcinoma. Gynecol Oncol. 2015 Sep;138(3):656-62. doi: 10.1016/j.ygyno.2015.06.033. Epub 2015 Jun 24.
PubMed 26115975Pan D, Kocherginsky M, Conzen SD. Activation of the glucocorticoid receptor is associated with poor prognosis in estrogen receptor-negative breast cancer. Cancer Res. 2011 Oct 15;71(20):6360-70. doi: 10.1158/0008-5472.CAN-11-0362. Epub 2011 Aug 25.
PubMed 21868756Wu W, Chaudhuri S, Brickley DR, Pang D, Karrison T, Conzen SD. Microarray analysis reveals glucocorticoid-regulated survival genes that are associated with inhibition of apoptosis in breast epithelial cells. Cancer Res. 2004 Mar 1;64(5):1757-64. doi: 10.1158/0008-5472.can-03-2546.
PubMed 14996737Kach J, Long TM, Selman P, Tonsing-Carter EY, Bacalao MA, Lastra RR, de Wet L, Comiskey S, Gillard M, VanOpstall C, West DC, Chan WC, Griend DV, Conzen SD, Szmulewitz RZ. Selective Glucocorticoid Receptor Modulators (SGRMs) Delay Castrate-Resistant Prostate Cancer Growth. Mol Cancer Ther. 2017 Aug;16(8):1680-1692. doi: 10.1158/1535-7163.MCT-16-0923. Epub 2017 Apr 20.
PubMed 28428441Kroon J, Puhr M, Buijs JT, van der Horst G, Hemmer DM, Marijt KA, Hwang MS, Masood M, Grimm S, Storm G, Metselaar JM, Meijer OC, Culig Z, van der Pluijm G. Glucocorticoid receptor antagonism reverts docetaxel resistance in human prostate cancer. Endocr Relat Cancer. 2016 Jan;23(1):35-45. doi: 10.1530/ERC-15-0343. Epub 2015 Oct 19.
PubMed 26483423Yemelyanov A, Bhalla P, Yang X, Ugolkov A, Iwadate K, Karseladze A, Budunova I. Differential targeting of androgen and glucocorticoid receptors induces ER stress and apoptosis in prostate cancer cells: a novel therapeutic modality. Cell Cycle. 2012 Jan 15;11(2):395-406. doi: 10.4161/cc.11.2.18945. Epub 2012 Jan 15.
PubMed 22223138Szmulewitz RZ, Chung E, Al-Ahmadie H, Daniel S, Kocherginsky M, Razmaria A, Zagaja GP, Brendler CB, Stadler WM, Conzen SD. Serum/glucocorticoid-regulated kinase 1 expression in primary human prostate cancers. Prostate. 2012 Feb 1;72(2):157-64. doi: 10.1002/pros.21416. Epub 2011 May 11.
PubMed 21563193Puhr M, Hoefer J, Eigentler A, Ploner C, Handle F, Schaefer G, Kroon J, Leo A, Heidegger I, Eder I, Culig Z, Van der Pluijm G, Klocker H. The Glucocorticoid Receptor Is a Key Player for Prostate Cancer Cell Survival and a Target for Improved Antiandrogen Therapy. Clin Cancer Res. 2018 Feb 15;24(4):927-938. doi: 10.1158/1078-0432.CCR-17-0989. Epub 2017 Nov 20.
PubMed 29158269
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03863145
- Acronym / sponsor ID
- CB-03-10/01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Mar 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.
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Detailed description
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1 (Dose Escalation): Subjects with advanced refractory solid tumors Part 2 (Dose Expansion): Defined subject subgroups considered likely to respond to CB-03-10 (eg, relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, triple-negative breast adenocarcinoma) or indications that demonstrated activity in Part 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CB-03-10Part 1 (Dose Escalation): 100 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent For Part 1 (Dose Escalation): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable to standard therapy For Part 2 (Dose Expansion): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific tumor subtype as determined by the SRC Age >18 years Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 For Part 1 (Dose Escalation): Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria For Part 2 (Dose Expansion): Measurable disease as per RECIST v1.1 criteria. Adequate renal, hepatic and bone marrow function as defined by Screening labs Negative pregnancy test for females of childbearing potential at the Screening Visit and use of appropriate method of birth control.
- EXCLUSION CRITERIA Pregnant or breastfeeding women Known central nervous system (CNS) metastases or spinal cord compression Known second cancer of other primary origin (excluding Stage I non-melanoma skin cancer and prostate cancer controlled with hormonal therapy) within the prior 5 years Active autoimmune disease Significant cardiac disease Uncontrolled hypertension Major surgery or irradiation within 28 days prior to start of study treatment Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from prior anticancer therapy Requirement for chronic corticosteroids or other immunosuppressant drugs Known infection with hepatitis B or C virus Known infection with HIV and CD4+ T-cell counts < 350 cells/uL Patients with an opportunistic infection within the past 12 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CB-03-10CB-03-10, 100 mg capsule for oral use | Drug | 1 |
Primary outcome
Determine the maximum tolerated dose
Time frame: 29 days
Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
Determine the dose-limiting toxicity
Time frame: 28 days
Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors
1 secondary outcome
Determine a recommended Phase 2 dose (RP2D) of CB-03-10
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Results publication: PubMed 7082756Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
- Results publication: PubMed 21969517Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
- Results publication: PubMed 24131140Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
- Results publication: PubMed 23341367Conroy T, Gavoille C, Samalin E, Ychou M, Ducreux M. The role of the FOLFIRINOX regimen for advanced pancreatic cancer. Curr Oncol Rep. 2013 Apr;15(2):182-9. doi: 10.1007/s11912-012-0290-4.
- Results publication: PubMed 25535299Brower V. New approaches tackle rising pancreatic cancer rates. J Natl Cancer Inst. 2014 Dec 22;106(12):dju417. doi: 10.1093/jnci/dju417. Print 2014 Dec. No abstract available.
- Results publication: PubMed 27300548Schweizer MT, Gulati R, Mostaghel EA, Nelson PS, Montgomery RB, Yu EY, Cheng HH. Docetaxel-related toxicity in metastatic hormone-sensitive and metastatic castration-resistant prostate cancer. Med Oncol. 2016 Jul;33(7):77. doi: 10.1007/s12032-016-0793-1. Epub 2016 Jun 14.
- Results publication: PubMed 28293120Block TS, Murphy TI, Munster PN, Nguyen DP, Lynch FJ. Glucocorticoid receptor expression in 20 solid tumor types using immunohistochemistry assay. Cancer Manag Res. 2017 Mar 6;9:65-72. doi: 10.2147/CMAR.S124475. eCollection 2017.
- Results publication: PubMed 26115975Stringer-Reasor EM, Baker GM, Skor MN, Kocherginsky M, Lengyel E, Fleming GF, Conzen SD. Glucocorticoid receptor activation inhibits chemotherapy-induced cell death in high-grade serous ovarian carcinoma. Gynecol Oncol. 2015 Sep;138(3):656-62. doi: 10.1016/j.ygyno.2015.06.033. Epub 2015 Jun 24.
- Results publication: PubMed 21868756Pan D, Kocherginsky M, Conzen SD. Activation of the glucocorticoid receptor is associated with poor prognosis in estrogen receptor-negative breast cancer. Cancer Res. 2011 Oct 15;71(20):6360-70. doi: 10.1158/0008-5472.CAN-11-0362. Epub 2011 Aug 25.
- Results publication: PubMed 14996737Wu W, Chaudhuri S, Brickley DR, Pang D, Karrison T, Conzen SD. Microarray analysis reveals glucocorticoid-regulated survival genes that are associated with inhibition of apoptosis in breast epithelial cells. Cancer Res. 2004 Mar 1;64(5):1757-64. doi: 10.1158/0008-5472.can-03-2546.
- Results publication: PubMed 28428441Kach J, Long TM, Selman P, Tonsing-Carter EY, Bacalao MA, Lastra RR, de Wet L, Comiskey S, Gillard M, VanOpstall C, West DC, Chan WC, Griend DV, Conzen SD, Szmulewitz RZ. Selective Glucocorticoid Receptor Modulators (SGRMs) Delay Castrate-Resistant Prostate Cancer Growth. Mol Cancer Ther. 2017 Aug;16(8):1680-1692. doi: 10.1158/1535-7163.MCT-16-0923. Epub 2017 Apr 20.
- Results publication: PubMed 26483423Kroon J, Puhr M, Buijs JT, van der Horst G, Hemmer DM, Marijt KA, Hwang MS, Masood M, Grimm S, Storm G, Metselaar JM, Meijer OC, Culig Z, van der Pluijm G. Glucocorticoid receptor antagonism reverts docetaxel resistance in human prostate cancer. Endocr Relat Cancer. 2016 Jan;23(1):35-45. doi: 10.1530/ERC-15-0343. Epub 2015 Oct 19.
- National Cancer Institute. Cancer of the Esophagus - SEER Stat Fact Sheets \[Internet\]. Cancer Statistics. 2015 \[cited 2015 Sep 15\].Link provided by the sponsor.
- International Council on Harmonisation. Addendum to ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population e11(r1). Vol. Step 4, ICH Harmonised Guideline E11 (R1). 2017.Link provided by the sponsor.
- International Conference on Harmonization Guidance on Good Clinical Practice \[Internet\]. \[cited 2016 Jan 1\].Link provided by the sponsor.
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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 Early Phase 1 study testing CB-03-10 in people with Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10, run by Cosmo Technologies Ltd 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 2 inclusion and 0 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 7 Feb 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Cristina Banyai (+353867015703, cbanyai@cosmopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose (time frame: 29 days). 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?
On the ClinicalTrials.gov record for NCT03863145, which also lists 22 linked publications.
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 7 Feb 2024.