CancerPhase 1NCT00504790
Phase I Study to Assess the Safety, Pharmacokinetics, & Pharmacodynamics of GSK923295 in Subjects w/ Refractory Cancer
A Phase 1 study testing GSK923295 in people with Cancer, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with cancers that do not respond to standard therapy. This study will be conducted in two stages; a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GSK923295
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2007to 8 May 2012
- 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
- Signed, written informed consent provided.
- a) Stage 1 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to accepted standard therapies, or for which there is no standard therapy.
- Stage 2 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia that is not responsive to accepted standard therapies, or for which there is no standard therapy.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- 18 years old or older.
- Male or female
Show all 22Show fewer
- A female is eligible to enroll in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:
- Has had a hysterectomy, or
- Has had a bilateral oophorectomy (ovariectomy), or
- Has had a bilateral tubal ligation, or
- Is post-menopausal (demonstrate total cessation of menses for greater than or equal to one year).
- Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following from at least two weeks prior to study enrolment until completion of the Post Study procedures:
- An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- Vasectomized partner who is sterile and is the sole sexual partner for that woman.
- Complete abstinence from sexual intercourse.
- Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
- A male is eligible to enter and participate in the study if he either agrees to abstain from sexual intercourse or use a condom and occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository from the first dose administered until completion of the Post-Treatment procedures; or is surgically sterile.
- Adequate organ systems function as defined in the protocol.
- Subjects may have measurable lesions according to RECIST criteria in Stage 1. It is required in Stage 2 that subjects with solid tumors have measurable lesions according to RECIST criteria.
- Paraffin-embedded archival tumor tissue available for testing.
- At least one target tumor accessible to serial core needle biopsies at study entry (screening) and one additional time point post-dose Cycle 1. Note: optional for Stage 1 (Dose Escalation); it is mandatory for Stage 2 (Expansion Cohort)
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Any major surgery OR prior anti-cancer therapy including but not limited to chemotherapy, radiotherapy, immunotherapy, biological therapy, or investigational therapy within the past 28 days (42 days for prior nitrosureas or mitomycin C).
- Prior allogeneic or autologous bone marrow transplant.
- Greater than 30% bone marrow irradiated.
- Unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy (except alopecia).
- History of hemolytic anemia (either congenital or acquired) OR current laboratory evidence of hemolysis (Grade 1CTCAE or greater) that includes at least one of the following:
Show all 22Show fewer
- Decrease in serum haptoglobin (outside normal institutional laboratory values)
- Increase in indirect bilirubin (outside normal institutional laboratory values)
- Peripheral blood smear consistent with hemolysis (presence of schistocytes)
- Pre-existing peripheral neuropathy or other neurological toxicity ≥ Grade 2.
- Female subjects who are pregnant or lactating.
- Any serious or unstable pre-existing medical, psychiatric, active infection or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent.
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
- QTc prolongation defined as a QTc interval greater than or equal to 450 msecs.
- Other significant ECG abnormalities including 2nd or 3rd degree AV block or bradycardia (ventricular rate less than 50 beats/min).
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
- For subjects with a history of myocardial infarction, congestive heart failure, abnormal left ventricular ejection fraction (LVEF), or prior anthracycline exposure, LVEF must be assessed within 28 days of the first dose of study drug by one of the following methods: MUGA or ECHO. An LVEF measurement of < 50% will exclude the subject from participation in the study.
- Class III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Current use of warfarin ≥ 4 mg per day. NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted. PT/PTT must meet the inclusion criteria.
- Current use of prohibited medications in accordance with the guidelines detailed in the protocol in the "Prohibited Medications" section.
- Current use of drugs with risk of torsade de pointes as described in the protocol.
- Evidence of symptomatic or untreated central nervous system involvement (i.e., brain metastases, leptomeningeal disease, cord compression).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Duarte, California, 91010
GSK Investigational Site
Madison, Wisconsin, 53792-5666
About this study
Official title: A Phase I, Open-Label, Dose-Escalation, First Time in Human Study to Evaluate the Safety Profile, Pharmacokinetics, and Pharmacodynamics of GSK923295 in Subjects With Refractory Cancers
This is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with cancers that do not respond to standard therapy. This study will be conducted in two stages; a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).
Read the detailed description
Centromere-associated protein E (CENP-E) is a protein that is required for correct chromosomal alignment in mitosis. Loss of CENP-E activity, due to microinjection of antibodies, ablation of gene expression with siRNA or antisense oligonucleotides, or inhibition of enzymatic activity by small molecule inhibitors, causes aberrant cell cycle arrest in mitosis, characterized by a bipolar mitotic spindle with misaligned chromosomes. Studies with small molecule inhibitors have demonstrated that this aberrant cell cycle arrest can result in apoptosis and cell death. CENP-E has been shown to be abundantly expressed in a variety of human tumors. GSK923295 is a potent and selective CENP-E inhibitor which has demonstrated potent and broad spectrum antitumor activity against solid and hematologic malignancies in vitro. GSK923295 is intended for use either as a monotherapy or in combination with existing anti-cancer therapies.
A drug targeting CENP-E may prove as efficacious as the taxanes and vinca alkaloids, without the potential for neurotoxicity or other side-effects associated with interference of tubulin function in non-dividing cells. Similar to many other anti-proliferative drugs, CENP-E inhibitors are expected to have manageable dose-limiting toxicities resulting from action on normal proliferating tissues (e.g., myelosuppression and gastrointestinal epithelial cell damage). The opportunity for inhibitors of CENP-E lies in the potential for broad efficacy. The absence of broad clinical experience with anti-mitotic cancer therapies acting on targets other than tubulin complicates prediction of additional benefits, beyond the lack of neurotoxicity that might accrue from a drug targeting CENPE.
The purpose of this Phase I, first time in human (FTIH) study in subjects with refractory cancers is to determine the maximally tolerated dose (MTD) (or recommended dose based on available safety, pharmacokinetic (PK) and response data), dose-limiting toxicities (DLTs), PK, pharmacodynamics (PD), and preliminary clinical activity of GSK923295, an inhibitor of CENP-E.
The primary objectives in Stage 1 (Dose Escalation) are:
- To determine the MTD (or recommended dose based on available safety, PK, and response data), DLTs, safety, and PK of GSK923295 administered to subjects with advanced, refractory malignancies.
The primary objectives in Stage 2 (Expansion Cohort) are:
- To evaluate the safety and PK of GSK923295 at the MTD (or recommended dose based on available safety, PK, and response data) administered to subjects with advanced, refractory malignancies.
Secondary Objectives in the study are:
- To determine the clinical activity of GSK923295 administered to subjects with advanced, refractory malignancies.
- To evaluate the effect of GSK923295 on biomarkers in normal host tissue (Stage 1 and 2) and tumor (Stage 2, optional in Stage 1) and the effect of GSK923295 on tumor metabolism with FDG-PET imaging (Stage 2, optional in Stage 1).
- Explore associations between biochemical and genetic characteristics of baseline archival tumor specimens (Stage 1 and Stage 2), biopsy-accessible tumor specimens (Stage 2), and anti-tumor response.
- Explore pharmacogenomic associations between genetic variants in drug metabolizing and drug transport genes and PK, safety, and efficacy of GSK923295.
The primary and secondary endpoint(s) used to assess the objective measures are:
Primary
- Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments will be evaluated to assess safety profile.
Secondary
- The MTD (or recommended dose based on available safety, PK, and response data) where no more than 1 of 6 subjects has a DLT in the first treatment cycle.
- PK parameters CL, Vdss, AUC(0-∞), AUC(0-t), Cmax, tmax, and t1/2 (Stage 1) and develop a PK model for GSK923295 (Stage 1 and 2).
- Anti-tumor activity measurements will be obtained at baseline and after every second cycle according to the following:
- Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines for solid tumors (for solid tumors and non-Hodgkin's lymphoma).
- National Cancer Institute - Working Group (NCI-WG) Guidelines for chronic lymphocytic leukaemia.
- Exploratory PK/PD modeling of safety and response data.
- Changes in biomarkers of cell proliferation and cell death or imaging endpoints.
- Biomarker profiles in archival tumor specimens and their correlation with clinical activity.
- Genetic polymorphisms in key enzymes involved in the metabolism and disposition of GSK923295 and correlations with pharmacokinetic, safety, and response (pharmacodynamic) data.
The study will consist of two stages. Stage 1 consists of a dose escalation stage to determine the MTD (or recommended dose based on available safety, PK and response data) using an accelerated titration scheme combined with standard dose escalation methods. GSK923295 will be administered intravenously over one hour, once weekly for 3 consecutive weeks (i.e., Day 1, 8, and 15) with treatment cycles repeated every 4 weeks (each cycle = 28 days). During Stage 1, safety, pharmacokinetics, pharmacodynamics, and clinical activity will be assessed. Tumor biopsies and PET imaging are optional in Stage 1 subjects. The MTD (or recommended dose based on available safety, PK and response data) will be defined as the dose of GSK923295 at which no more than 1 of 6 subjects experiences a DLT in the first treatment cycle. Eighteen subjects are anticipated to participate in Stage 1 of the study. In Stage 2, 15-20 additional subjects will be enrolled at the MTD (or recommended dose based on available safety, PK and response data) dose to further evaluate the safety of GSK923295. In Stage 2, PK samples (using a sparse PK sampling scheme for population PK analyses), PET imaging, and tumor biopsies will be obtained. Clinical activity will be assessed. Subjects (Stage 1 and Stage 2) will remain on study until they meet the criteria for treatment discontinuation described in the protocol. It is anticipated that 33-38 subjects will participate in the study (18 in Stage 1 and 15-20 in Stage 2. During Stage 1 and Stage 2, subjects with histologically confirmed advanced refractory solid tumors will be enrolled. In Stage 2, subjects with refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia can also be enrolled.
- Conditions
- Cancer
- Being tested
- GSK923295
- Keywords
- GSK923295,, First Time in Human,, pharmacodynamics, cancer,, maximally tolerated dose, pharmacokinetics,, Refractory Cancer, CENPE,, Phase I,
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK923295Drug
anti-mitotic compound
| Study group | Role | What they receive |
|---|---|---|
| GSK923295 | Experimental | anti-mitotic compound under study Receives: Drug: GSK923295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: - physical exam
Measured: at screen & Day(D) 1 of each cycle and follow-up(F/U)
- vital signs and lab tests
Measured: at screen & D1, 8, 15, & 22 for each cycle & F/U
- ECGs
Measured: at screen and D1, 8 & 15 for each cycle & F/U
continuous monitoring of adverse events
Measured: each visit
Secondary outcomes (2)
Plasma samples of GSK923295 taken at:
used to measure levels of the drug in blood over time
Measured: - Day 1 & 15 (Cycle 1) for Stage 1
Plasma samples of GSK923295 taken at:
used to monitor levels of the drug in blood
Measured: - Day 1 of each cycle for Stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study start25 Jun 2007
- Primary completion7 May 2012
- Study completion8 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504790
- Sponsor's protocol ID
- CPE107602
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2007
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Chung V, Fleming RA, Johnson BM, Gauvin J, Cyr TL, Lager JJ, Lu E, Alberti DB, Williams B, Weber BL, Synold T, Holen KD. A phase 1 and first time in human study of the centromere associated protein E (CENP-E) inhibitor GSK923295A in patients with advanced solid rumors. American Association of Clinical Research Annual Meeting 2008, Oral Presentation, Abstract LB 246
Fleming RA, Holen KD, Cyr TL, Johnson BM, Gauvin JL, Lager JJ, Williams B, Alberti DB, Weber BL, Grilley-Olson JE, Chung V. A phase I dose escalation and pharmacokinetic study of the novel mitotic checkpoint inhibitor GSK923295A in patients with solid tumors. (Poster). EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Meeting, Geneva, Switzerland, 2008
Holen KD, Heath E, Shelman WS, Kirby LC, Johnson BM, Botbyl JD, Grilley-Olson JE, Lampkin TA, Chung V. Phase I, first-in-human study of the centromere-associated protein e (CENP-E) inhibitor GSK923295 in patients with advanced solid tumors (Study CPE107602). American Society of Clinical Oncology 2010, Oral Presentation, Abstract 3012
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation, First Time in Human Study to Evaluate the Safety Profile, Pharmacokinetics, and Pharmacodynamics of GSK923295 in Subjects With Refractory Cancers
- ClinicalTrials.gov ID
- NCT00504790
- Acronym / sponsor ID
- CPE107602
- Conditions
- Cancer
- Keywords
- GSK923295,, First Time in Human,, pharmacodynamics, cancer,, maximally tolerated dose, pharmacokinetics,, Refractory Cancer, CENPE,, Phase I,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2007 (actual)
- Primary completion
- 7 May 2012 (actual)
- Study completion
- 8 May 2012 (actual)
- First posted
- 20 Jul 2007 (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 is a Phase I, open-label, first time in human study of GSK923295, in adult subjects with cancers that do not respond to standard therapy. This study will be conducted in two stages; a dose-escalation stage (Stage 1) and an expansion cohort stage (Stage 2).
Detailed description
Centromere-associated protein E (CENP-E) is a protein that is required for correct chromosomal alignment in mitosis. Loss of CENP-E activity, due to microinjection of antibodies, ablation of gene expression with siRNA or antisense oligonucleotides, or inhibition of enzymatic activity by small molecule inhibitors, causes aberrant cell cycle arrest in mitosis, characterized by a bipolar mitotic spindle with misaligned chromosomes. Studies with small molecule inhibitors have demonstrated that this aberrant cell cycle arrest can result in apoptosis and cell death. CENP-E has been shown to be abundantly expressed in a variety of human tumors. GSK923295 is a potent and selective CENP-E inhibitor which has demonstrated potent and broad spectrum antitumor activity against solid and hematologic malignancies in vitro. GSK923295 is intended for use either as a monotherapy or in combination with existing anti-cancer therapies.
A drug targeting CENP-E may prove as efficacious as the taxanes and vinca alkaloids, without the potential for neurotoxicity or other side-effects associated with interference of tubulin function in non-dividing cells. Similar to many other anti-proliferative drugs, CENP-E inhibitors are expected to have manageable dose-limiting toxicities resulting from action on normal proliferating tissues (e.g., myelosuppression and gastrointestinal epithelial cell damage). The opportunity for inhibitors of CENP-E lies in the potential for broad efficacy. The absence of broad clinical experience with anti-mitotic cancer therapies acting on targets other than tubulin complicates prediction of additional benefits, beyond the lack of neurotoxicity that might accrue from a drug targeting CENPE.
The purpose of this Phase I, first time in human (FTIH) study in subjects with refractory cancers is to determine the maximally tolerated dose (MTD) (or recommended dose based on available safety, pharmacokinetic (PK) and response data), dose-limiting toxicities (DLTs), PK, pharmacodynamics (PD), and preliminary clinical activity of GSK923295, an inhibitor of CENP-E.
The primary objectives in Stage 1 (Dose Escalation) are:
- To determine the MTD (or recommended dose based on available safety, PK, and response data), DLTs, safety, and PK of GSK923295 administered to subjects with advanced, refractory malignancies.
The primary objectives in Stage 2 (Expansion Cohort) are:
- To evaluate the safety and PK of GSK923295 at the MTD (or recommended dose based on available safety, PK, and response data) administered to subjects with advanced, refractory malignancies.
Secondary Objectives in the study are:
- To determine the clinical activity of GSK923295 administered to subjects with advanced, refractory malignancies.
- To evaluate the effect of GSK923295 on biomarkers in normal host tissue (Stage 1 and 2) and tumor (Stage 2, optional in Stage 1) and the effect of GSK923295 on tumor metabolism with FDG-PET imaging (Stage 2, optional in Stage 1).
- Explore associations between biochemical and genetic characteristics of baseline archival tumor specimens (Stage 1 and Stage 2), biopsy-accessible tumor specimens (Stage 2), and anti-tumor response.
- Explore pharmacogenomic associations between genetic variants in drug metabolizing and drug transport genes and PK, safety, and efficacy of GSK923295.
The primary and secondary endpoint(s) used to assess the objective measures are:
Primary
- Adverse events (AE) and changes from baseline in vital signs, clinical laboratory parameters, and electrocardiography (ECG) assessments will be evaluated to assess safety profile.
Secondary
- The MTD (or recommended dose based on available safety, PK, and response data) where no more than 1 of 6 subjects has a DLT in the first treatment cycle.
- PK parameters CL, Vdss, AUC(0-∞), AUC(0-t), Cmax, tmax, and t1/2 (Stage 1) and develop a PK model for GSK923295 (Stage 1 and 2).
- Anti-tumor activity measurements will be obtained at baseline and after every second cycle according to the following:
- Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines for solid tumors (for solid tumors and non-Hodgkin's lymphoma).
- National Cancer Institute - Working Group (NCI-WG) Guidelines for chronic lymphocytic leukaemia.
- Exploratory PK/PD modeling of safety and response data.
- Changes in biomarkers of cell proliferation and cell death or imaging endpoints.
- Biomarker profiles in archival tumor specimens and their correlation with clinical activity.
- Genetic polymorphisms in key enzymes involved in the metabolism and disposition of GSK923295 and correlations with pharmacokinetic, safety, and response (pharmacodynamic) data.
The study will consist of two stages. Stage 1 consists of a dose escalation stage to determine the MTD (or recommended dose based on available safety, PK and response data) using an accelerated titration scheme combined with standard dose escalation methods. GSK923295 will be administered intravenously over one hour, once weekly for 3 consecutive weeks (i.e., Day 1, 8, and 15) with treatment cycles repeated every 4 weeks (each cycle = 28 days). During Stage 1, safety, pharmacokinetics, pharmacodynamics, and clinical activity will be assessed. Tumor biopsies and PET imaging are optional in Stage 1 subjects. The MTD (or recommended dose based on available safety, PK and response data) will be defined as the dose of GSK923295 at which no more than 1 of 6 subjects experiences a DLT in the first treatment cycle. Eighteen subjects are anticipated to participate in Stage 1 of the study. In Stage 2, 15-20 additional subjects will be enrolled at the MTD (or recommended dose based on available safety, PK and response data) dose to further evaluate the safety of GSK923295. In Stage 2, PK samples (using a sparse PK sampling scheme for population PK analyses), PET imaging, and tumor biopsies will be obtained. Clinical activity will be assessed. Subjects (Stage 1 and Stage 2) will remain on study until they meet the criteria for treatment discontinuation described in the protocol. It is anticipated that 33-38 subjects will participate in the study (18 in Stage 1 and 15-20 in Stage 2. During Stage 1 and Stage 2, subjects with histologically confirmed advanced refractory solid tumors will be enrolled. In Stage 2, subjects with refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia can also be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK923295 | Experimental | Drug: GSK923295anti-mitotic compound under study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed, written informed consent provided.
- a) Stage 1 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to accepted standard therapies, or for which there is no standard therapy.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- 18 years old or older.
- Male or female
Key exclusion criteria (22 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Any major surgery OR prior anti-cancer therapy including but not limited to chemotherapy, radiotherapy, immunotherapy, biological therapy, or investigational therapy within the past 28 days (42 days for prior nitrosureas or mitomycin C).
- Prior allogeneic or autologous bone marrow transplant.
- Greater than 30% bone marrow irradiated.
- Unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy (except alopecia).
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 |
|---|---|---|
| GSK923295anti-mitotic compound | Drug | GSK923295 |
Primary outcome
Safety: - physical exam
Time frame: at screen & Day(D) 1 of each cycle and follow-up(F/U)
- vital signs and lab tests
Time frame: at screen & D1, 8, 15, & 22 for each cycle & F/U
- ECGs
Time frame: at screen and D1, 8 & 15 for each cycle & F/U
continuous monitoring of adverse events
Time frame: each visit
2 secondary outcomes
Plasma samples of GSK923295 taken at:
Time frame: - Day 1 & 15 (Cycle 1) for Stage 1
Plasma samples of GSK923295 taken at:
Time frame: - Day 1 of each cycle for Stage 2
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 12 Jul 2018.
- Results publicationChung V, Fleming RA, Johnson BM, Gauvin J, Cyr TL, Lager JJ, Lu E, Alberti DB, Williams B, Weber BL, Synold T, Holen KD. A phase 1 and first time in human study of the centromere associated protein E (CENP-E) inhibitor GSK923295A in patients with advanced solid rumors. American Association of Clinical Research Annual Meeting 2008, Oral Presentation, Abstract LB 246
- Results publicationFleming RA, Holen KD, Cyr TL, Johnson BM, Gauvin JL, Lager JJ, Williams B, Alberti DB, Weber BL, Grilley-Olson JE, Chung V. A phase I dose escalation and pharmacokinetic study of the novel mitotic checkpoint inhibitor GSK923295A in patients with solid tumors. (Poster). EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Meeting, Geneva, Switzerland, 2008
- Results publicationHolen KD, Heath E, Shelman WS, Kirby LC, Johnson BM, Botbyl JD, Grilley-Olson JE, Lampkin TA, Chung V. Phase I, first-in-human study of the centromere-associated protein e (CENP-E) inhibitor GSK923295 in patients with advanced solid tumors (Study CPE107602). American Society of Clinical Oncology 2010, Oral Presentation, Abstract 3012
- Results for study CPE107602 can be found on the GSK Clinical Study Register.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.
GSK Clinical Trials study director
GlaxoSmithKline
3 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 GSK923295 in people with Cancer, run by GlaxoSmithKline 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 22 inclusion and 22 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 12 Jul 2018. 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 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?
Safety: - physical exam (time frame: at screen & Day(D) 1 of each cycle and follow-up(F/U)). The study lists 4 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 NCT00504790, which also lists 3 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 12 Jul 2018.