Solid TumorsPhase 1/2NCT02632448
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
A Phase 1/2 study testing LY2880070 and Gemcitabine in people with Solid Tumors and Colorectal Cancer, run by Esperas Pharma Inc. at 16 sites in 4 countries.
Trial summary
The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Colorectal Cancer, Breast Cancer
- What is being tested?
- LY2880070 and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 16 May 2016to 14 Apr 2025
- 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
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy of greater than or equal to (≥)12 weeks
- Have adequate organ function
- Have received 1-4 prior systemic therapies for locally advanced or metastatic disease
- Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
- All females must have a negative serum pregnancy test result, and females of child-bearing potential must have a negative urine pregnancy test result, prior to the first study treatment
Show all 34Show fewer
- Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit
- For Part A
- Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
- For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype
- For Part B
- Have advanced or metastatic colorectal cancer, triple negative breast cancer (per American Society of Clinical Oncology-College of American Pathology guidelines), epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer
- For TNBC:
- Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any beast cancer that expresses <1% estrogen receptor (ER) and <1% progesterone receptor (PR) and is Her2 negative
- For Colorectal (CRC):
- Must have histologically confirmed advanced or metastatic colorectal cancer
- For Ovarian Cancer:
- Must have histologically confirmed advanced or metastatic epithelial ovarian cancer
- Must be eligible to receive Gemzar (GEM) and not refractory to GEM/carboplatin
- Must have the ability to tolerate GEM
- May have received GEM as previous therapy
- For Endometrial cancer:
- Must have histologically confirmed endometrial cancer that is metastatic or locally advanced
- Must have failed at least 1 prior chemotherapy
- For STS:
- Must have histologically confirmed STS that is metastatic or locally advanced
- Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT inhibitor
- Must have failed at least 1 prior chemotherapy
- For Pancreatic Cancer:
- Must have histologically confirmed pancreatic cancer that is metastatic or locally advanced
- Must have failed at least 1 prior chemotherapy regimen
- For Part C
- Participants with high grade serous ovarian cancer (HGSOC) will be screened for specific genetic signatures
Who cannot join
- Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
- Have symptomatic central nervous system (CNS) metastasis
- Females who are pregnant or nursing
- Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
- Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female) or >450 msec (male), or a history of congenital long QT syndrome
- Have had a bone marrow transplant
Show all 10Show fewer
- Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product
- Have had radiation therapy to >25% of bone marrow
- For Part B
- Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered cured
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Canada8 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
University Health Network - Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Poland4 sites
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, 85-796
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, 80-214
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o. o.
Krakow, 30-348
Szpital Specjalistyczny im. L. Rydygiera w Krakowie sp. z o. o.
Krakow, 31-826
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
Croatia2 sites
General Hospital Zadar
Zadar, 23000
University Hospital Centre Zagreb
Zagreb, 10000
About this study
Official title: A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer
The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
- Conditions
- Solid Tumors, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Colon Cancer, Rectal Cancer
- Being tested
- LY2880070, Gemcitabine
- Keywords
- Metastatic cancer, Advanced cancer, Recurrent cancer, Colorectal neoplasms, Triple negative breast cancer, Ovarian neoplasms, Colon neoplasms, Rectal neoplasms, Triple negative breast neoplasms, Gastrointestinal stromal tumor, Pancreatic Neoplasms, Pancreatic Cancer
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasms, Endometrial Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2880070Drug
Capsules
GemcitabineDrug
Also called Gemzar
50 to 600 milligrams per square meter of body surface area (mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY2880070 | Experimental | Multiple oral doses of LY2880070 during 21-day cycles Receives: Drug: LY2880070 |
| Part A: LY2880070 with Gemcitabine | Experimental | Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part A: LY2880070 (Metabolism Phenotype) | Experimental | Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers Receives: Drug: LY2880070 |
| Part B: LY2880070 and Gemcitabine (Breast) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part B: LY2880070 and Gemcitabine (Colorectal) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part B:LY2880070 and Gemcitabine (Ovarian) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part B: LY2880070 and Gemcitabine (Endometrial) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part B: LY2880070 and Gemcitabine (Pancreatic) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
| Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) | Experimental | Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) Receives: Drug: LY2880070; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(s)
Measured: Baseline through Cycle 1 (Estimated up to 21 days)
Secondary outcomes (12)
Number of dose limiting toxicities (DLTs)
Measured: Baseline through Cycle 1 (Estimated up to 21 days)
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Measured: Baseline to 24-hours post dose (up to Day 20 in Cycle 1)
Peak plasma concentration (Cmax)
Measured: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Time to reach maximum plasma concentration (tmax)
Measured: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in white blood cell count
Measured: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in neutrophil count
Measured: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in lymphocyte count
Measured: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Measured: Baseline to study completion (estimated up to 4 years)
Duration of objective response
Measured: Baseline to study completion (estimated up to 4 years)
Best response
Measured: Baseline to study completion (estimated up to 4 years)
Progression free survival
Measured: Baseline to study completion (estimated up to 4 years)
Overall survival
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start16 May 2016
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esperas Pharma Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Email: Darcy.Vincett@ozmosisresearch.ca, Study director, Esperas Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632448
- Sponsor's protocol ID
- ESPS-001
- Status last verified
- Apr 2025
- First submitted
- 14 Dec 2015
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
W.H. Miller, A.F. Shields, D. Provencher, L. Gilbert, G. Shapiro, A.M. Oza, J. Spratlin, S. Lheureux, G. Bhat, S. Salvador, P. Nunes, S. Lau, I. Weiner, J. Keene, S. Zaknoen, P. Smith, J. Stille, D. Vincett, Q.S-C. Chu, 537P A phase I/II study of oral chk1 inhibitor LY2880070 in combination with low-dose gemcitabine in patients with advanced or metastatic ovarian cancer, Annals of Oncology, Volume 33, Supplement 7, 2022, Pages S793-S794, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2022.07.665. (https://www.sciencedirect.com/science/article/pii/S0923753422025169)
DOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.
DOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.
Huffman BM, Feng H, Parmar K, Wang J, Kapner KS, Kochupurakkal B, Martignetti DB, Sadatrezaei G, Abrams TA, Biller LH, Giannakis M, Ng K, Patel AK, Perez KJ, Singh H, Rubinson DA, Schlechter BL, Andrews E, Hannigan AM, Dunwell S, Getchell Z, Raghavan S, Wolpin BM, Fortier C, D'Andrea AD, Aguirre AJ, Shapiro GI, Cleary JM. A Phase I Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-dose Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma. Clin Cancer Res. 2023 Dec 15;29(24):5047-5056. doi: 10.1158/1078-0432.CCR-23-2005.
PubMed 37819936
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02632448
- Acronym / sponsor ID
- ESPS-001
- Conditions
- Solid Tumors, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Colon Cancer, Rectal Cancer
- Keywords
- Metastatic cancer, Advanced cancer, Recurrent cancer, Colorectal neoplasms, Triple negative breast cancer, Ovarian neoplasms, Colon neoplasms, Rectal neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Esperas Pharma Inc.University, hospital or other
- Study start
- 16 May 2016 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 16 Dec 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.
The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: LY2880070 | Experimental | Drug: LY2880070Multiple oral doses of LY2880070 during 21-day cycles |
| Part A: LY2880070 with Gemcitabine | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles |
| Part A: LY2880070 (Metabolism Phenotype) | Experimental | Drug: LY2880070Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers |
| Part B: LY2880070 and Gemcitabine (Breast) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part B: LY2880070 and Gemcitabine (Colorectal) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part B:LY2880070 and Gemcitabine (Ovarian) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part B: LY2880070 and Gemcitabine (Endometrial) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part B: LY2880070 and Gemcitabine (Pancreatic) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
| Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) | Experimental | Drug: LY2880070, Drug: GemcitabineMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy of greater than or equal to (≥)12 weeks
- Have adequate organ function
- Have received 1-4 prior systemic therapies for locally advanced or metastatic disease
- Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
Key exclusion criteria (10 listed)
- Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
- Have symptomatic central nervous system (CNS) metastasis
- Females who are pregnant or nursing
- Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
- Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female) or >450 msec (male), or a history of congenital long QT syndrome
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 |
|---|---|---|
| LY2880070Capsules | Drug | Part A: LY2880070, Part A: LY2880070 (Metabolism Phenotype), Part A: LY2880070 with Gemcitabine, Part B: LY2880070 and Gemcitabine (Breast), Part B: LY2880070 and Gemcitabine (Colorectal), Part B: LY2880070 and Gemcitabine (Endometrial), Part B: LY2880070 and Gemcitabine (Pancreatic), Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)), Part B:LY2880070 and Gemcitabine (Ovarian), Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) |
| GemcitabineAlso: Gemzar50 to 600 milligrams per square meter of body surface area (mg/m2) | Drug | Part A: LY2880070 with Gemcitabine, Part B: LY2880070 and Gemcitabine (Breast), Part B: LY2880070 and Gemcitabine (Colorectal), Part B: LY2880070 and Gemcitabine (Endometrial), Part B: LY2880070 and Gemcitabine (Pancreatic), Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)), Part B:LY2880070 and Gemcitabine (Ovarian), Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer) |
Primary outcome
Maximum Tolerated Dose(s)
Time frame: Baseline through Cycle 1 (Estimated up to 21 days)
12 secondary outcomes
Number of dose limiting toxicities (DLTs)
Time frame: Baseline through Cycle 1 (Estimated up to 21 days)
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Time frame: Baseline to 24-hours post dose (up to Day 20 in Cycle 1)
Peak plasma concentration (Cmax)
Time frame: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Time to reach maximum plasma concentration (tmax)
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in white blood cell count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in neutrophil count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Change from baseline in lymphocyte count
Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Time frame: Baseline to study completion (estimated up to 4 years)
Duration of objective response
Time frame: Baseline to study completion (estimated up to 4 years)
Best response
Time frame: Baseline to study completion (estimated up to 4 years)
Progression free survival
Time frame: Baseline to study completion (estimated up to 4 years)
Overall survival
Time frame: Baseline up to 1 year
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 2 May 2025.
- Results publicationW.H. Miller, A.F. Shields, D. Provencher, L. Gilbert, G. Shapiro, A.M. Oza, J. Spratlin, S. Lheureux, G. Bhat, S. Salvador, P. Nunes, S. Lau, I. Weiner, J. Keene, S. Zaknoen, P. Smith, J. Stille, D. Vincett, Q.S-C. Chu, 537P A phase I/II study of oral chk1 inhibitor LY2880070 in combination with low-dose gemcitabine in patients with advanced or metastatic ovarian cancer, Annals of Oncology, Volume 33, Supplement 7, 2022, Pages S793-S794, ISSN 0923-7534, https://doi.org/10.1016/j.annonc.2022.07.665. (https://www.sciencedirect.com/science/article/pii/S0923753422025169)
- Results publicationDOI: 10.1200/JCO.2020.38.15_suppl.3579 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3579-3579.
- Results publicationDOI: 10.1200/JCO.2020.38.15_suppl.3581 Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020) 3581-3581.
- Derived from this study: PubMed 37819936Huffman BM, Feng H, Parmar K, Wang J, Kapner KS, Kochupurakkal B, Martignetti DB, Sadatrezaei G, Abrams TA, Biller LH, Giannakis M, Ng K, Patel AK, Perez KJ, Singh H, Rubinson DA, Schlechter BL, Andrews E, Hannigan AM, Dunwell S, Getchell Z, Raghavan S, Wolpin BM, Fortier C, D'Andrea AD, Aguirre AJ, Shapiro GI, Cleary JM. A Phase I Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-dose Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma. Clin Cancer Res. 2023 Dec 15;29(24):5047-5056. doi: 10.1158/1078-0432.CCR-23-2005.
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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.
Email: Darcy.Vincett@ozmosisresearch.ca study director
Esperas Pharma Inc.
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY2880070 and Gemcitabine in people with Solid Tumors and Colorectal Cancer, run by Esperas Pharma Inc. at 16 sites in 4 countries.
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 34 inclusion and 10 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, Poland, United States, Croatia. 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?
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?
Maximum Tolerated Dose(s) (time frame: Baseline through Cycle 1 (Estimated up to 21 days)). 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 NCT02632448, which also lists 4 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 2 May 2025.