Advanced Malignant NeoplasmPhase 1NCT03051035
First-in-Human Study of KO-947 in Non-Hematological Malignancies
A Phase 1 study testing KO-947 in people with Advanced Malignant Neoplasm, run by Kura Oncology, Inc. at 5 sites in 2 countries.
Trial summary
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- KO-947
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Apr 2017to 2 Jun 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
- Subject has a locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancy for which treatment with an approved agent that is considered standard of care in the indication either does not exist or has proven ineffective.
- To be enrolled in the dose escalation or in the MTD expansion, Subject must have a locally confirmed diagnosis of either of the following tumor types:
- Malignancy of non-squamous histology that carries a BRAF, KRAS, NRAS or HRAS mutation(s).
- Malignancy of squamous histology. In cases of mixed histology, squamous must be the predominant histology.
- Upon the identification of an MTD or RP2D, the Sponsor, in consultation with the study investigators, may open the enrollment of two of the following nonrandomized tumor specific extension cohorts: Subject must have a locally confirmed diagnosis of either of the following tumor types:
- RASMUT/BRAFMUT NSCLC: Subject must have a locally confirmed diagnosis of RAS (NRAS, KRAS, HRAS) or BRAF mutated non-small cell malignancies of the lung. Subject must have received at least 1 prior approved regimen for locally advanced or metastatic disease followed by documented progressive disease.
Show all 19Show fewer
- SCCHN and/or SCCE: Subject must have a locally confirmed diagnosis of SCCHN or SCCE with amplification of the 11q13 chromosome. Subject must have received at least 1 prior approved agent for advanced or metastatic disease followed by documented progressive disease. For subjects with 11q13 amplification, the tumor must have >3 copies of the 11q13 chromosome as determined by a methodology approved by the Sponsor.
- Subject has at least one measurable lesion per RECIST v1.1.
- For the MTD/RP2D expansion cohort, Subject must have an accessible tumor lesion(s) and consent to tumor biopsy of such a lesion(s) during screening and after starting KO-947 treatment for the analysis of ERK pathway signalling and biological effects.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Serum albumin ≥ 2.8 g/dL
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal (x ULN); if liver metastases are present, then ≤ 2 x ULN is allowed. Criteria does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN; if liver metastases are present, then ≤ 5 x ULN is allowed.
- Acceptable renal function with serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) ≥ 1500 cells/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
Who cannot join
- Ongoing treatment with an anticancer agent.
- History of prior significant toxicity (Grade 2 or higher that required permanent treatment discontinuation) from a BRAF, MEK (MAPK [Mitogen-activated protein]/ERK kinase) or ERK inhibitor.
- History of retinal vein occlusion, neurosensory retinal detachment, or neovascular macular degeneration. Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment.
- Mean QTcF of >470 ms on triplicate ECGs performed within 5 minutes of each other; subjects currently taking drugs known to be associated with prolonging the QT interval for which there are no adequate therapeutic substitutes; subjects with congenital long QT syndrome. As a guide to known drugs associated with QTc prolongation, please refer to the following Credible Meds web page for a list of drugs that prolong QT and/or cause torsades de pointes, https://crediblemeds.org/pdftemp/pdf/CombinedList.pdf
- Allergy or hypersensitivity to components of the KO-947 formulation, e.g. dextrose, hydroxypropyl beta cyclodextrin, acetic acid, sodium acetate and water for injection.
- Participation in any interventional study within 4 weeks of Cycle 1 Day 1 or 5 half-lives of the investigational agent(s) used in the interventional study prior to Cycle 1 Day 1 (whichever is shorter).
Show all 11Show fewer
- Grade >1 gastrointestinal toxicity that cannot be managed with supportive care measures.
- Received treatment for unstable angina within the prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Cycle 1 Day 1.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Mayo Clinic
Rochester, Minnesota, 55902
Spain2 sites
Vall D'Hebron Institute of Oncology
Barcelona, 08035
START Madrid-HM CIOCC
Madrid, 28050
About this study
Official title: A Phase 1 First-in-Human Study of KO-947 in Locally Advanced Unresectable or Metastatic, Relapsed and/or Refractory Non-Hematological Malignancies
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.
Read the detailed description
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity. Three dosing schedules will be executed (Schedule 1, 2, or 3).
Screening evaluations will be completed following signing of informed consent and within either 21 days or 28 days of Cycle 1 Day 1. Evaluations performed as part of the standard of care within 21/28 days of dosing but prior to consent do not need to be repeated. By signing the consent form, study subjects agree to the collection of standard of care health information.
The study will consist of three parts: dose escalation, MTD expansion and tumor specific extension.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- KO-947
- Keywords
- non-hematological malignancies, non-squamous, squamous, BRAF, KRAS, NRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KO-947Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| KO-947 | Experimental | Not described Receives: Drug: KO-947 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies.
Measured: Dose-limiting toxicities will be evaluated during the first 28 days of KO-947 monotherapy treatment in the dose escalation portion of the study.
Secondary outcomes (10)
Number of patients that experience Adverse Events (AEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be graded according to the NCI-CTCAE (Version 4.03)
Measured: Until 30 days after the end of study
Maximum plasma concentration (Cmax) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Plasma concentration of KO-947 over 24 hours after dosing on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Time to maximum plasma concentration (tmax) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Time to the last detectable plasma concentration (tlast) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Terminal half-life (t½λz) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Area under the plasma concentration-time curve for KO-947 from zero to 24 hours [AUC(0-24)] on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Area under the plasma concentration-time curve for KO-947 from zero to the last detectable plasma concentration [AUC(0-last)] on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Trough plasma concentration (Ctrough) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Measured: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Objective Response Rate (ORR), Progression Free Survival (PFS) and Duration of Response (DOR) of KO-947
Tumor assessments will be performed approximately every 12 weeks (Schedules 1 and 2) or every 9 weeks (Schedule 3) until disease progression.
Measured: 36 months (approximately 24 months accrual + 12 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start6 Apr 2017
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Why it stopped: Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kura Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051035
- Sponsor's protocol ID
- KO-ERK-001
- Status last verified
- Sep 2021
- First submitted
- 30 Jan 2017
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study of KO-947 in Locally Advanced Unresectable or Metastatic, Relapsed and/or Refractory Non-Hematological Malignancies
- ClinicalTrials.gov ID
- NCT03051035
- Acronym / sponsor ID
- KO-ERK-001
- Conditions
- Advanced Malignant Neoplasm
- Keywords
- non-hematological malignancies, non-squamous, squamous, BRAF, KRAS, NRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kura Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 13 Feb 2017 (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.
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.
Detailed description
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity. Three dosing schedules will be executed (Schedule 1, 2, or 3).
Screening evaluations will be completed following signing of informed consent and within either 21 days or 28 days of Cycle 1 Day 1. Evaluations performed as part of the standard of care within 21/28 days of dosing but prior to consent do not need to be repeated. By signing the consent form, study subjects agree to the collection of standard of care health information.
The study will consist of three parts: dose escalation, MTD expansion and tumor specific extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KO-947 | Experimental | Drug: KO-947 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject has a locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancy for which treatment with an approved agent that is considered standard of care in the indication either does not exist or has proven ineffective.
- To be enrolled in the dose escalation or in the MTD expansion, Subject must have a locally confirmed diagnosis of either of the following tumor types:
- Upon the identification of an MTD or RP2D, the Sponsor, in consultation with the study investigators, may open the enrollment of two of the following nonrandomized tumor specific extension cohorts: Subject must have a locally confirmed diagnosis of either of the following tumor types:
- Subject has at least one measurable lesion per RECIST v1.1.
- For the MTD/RP2D expansion cohort, Subject must have an accessible tumor lesion(s) and consent to tumor biopsy of such a lesion(s) during screening and after starting KO-947 treatment for the analysis of ERK pathway signalling and biological effects.
Key exclusion criteria (11 listed)
- Ongoing treatment with an anticancer agent.
- History of prior significant toxicity (Grade 2 or higher that required permanent treatment discontinuation) from a BRAF, MEK (MAPK [Mitogen-activated protein]/ERK kinase) or ERK inhibitor.
- History of retinal vein occlusion, neurosensory retinal detachment, or neovascular macular degeneration. Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment.
- Mean QTcF of >470 ms on triplicate ECGs performed within 5 minutes of each other; subjects currently taking drugs known to be associated with prolonging the QT interval for which there are no adequate therapeutic substitutes; subjects with congenital long QT syndrome. As a guide to known drugs associated with QTc prolongation, please refer to the following Credible Meds web page for a list of drugs that prolong QT and/or cause torsades de pointes, https://crediblemeds.org/pdftemp/pdf/CombinedList.pdf
- Allergy or hypersensitivity to components of the KO-947 formulation, e.g. dextrose, hydroxypropyl beta cyclodextrin, acetic acid, sodium acetate and water for injection.
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 |
|---|---|---|
| KO-947Intravenous administration | Drug | KO-947 |
Primary outcome
To determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies.
Time frame: Dose-limiting toxicities will be evaluated during the first 28 days of KO-947 monotherapy treatment in the dose escalation portion of the study.
10 secondary outcomes
Number of patients that experience Adverse Events (AEs)
Time frame: Until 30 days after the end of study
Maximum plasma concentration (Cmax) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Plasma concentration of KO-947 over 24 hours after dosing on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Time to maximum plasma concentration (tmax) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Time to the last detectable plasma concentration (tlast) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Terminal half-life (t½λz) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Area under the plasma concentration-time curve for KO-947 from zero to 24 hours [AUC(0-24)] on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Area under the plasma concentration-time curve for KO-947 from zero to the last detectable plasma concentration [AUC(0-last)] on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Trough plasma concentration (Ctrough) of KO-947 on Cycle 1 Day 1 and Cycle 2 Day 1
Time frame: Blood samples for determination of KO-947 concentration will be collected at 0, 1, end of infusion, 1.5 2, 2.5 3, 3.5, 4, 6, 8, 24 hours during dose escalation and dose expansion.
Objective Response Rate (ORR), Progression Free Survival (PFS) and Duration of Response (DOR) of KO-947
Time frame: 36 months (approximately 24 months accrual + 12 months follow-up)
Results and safety
The study was stopped early (reason given: Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Malignant Neoplasm
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KO-947 in people with Advanced Malignant Neoplasm, run by Kura Oncology, Inc. at 5 sites in 2 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 19 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain. 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 was stopped early (reason given: Due to a strategic business decision Kura has stopped development of KO-947. Neither safety nor efficacy reasons were the cause of study termination.). Results are not available in the source record.
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?
To determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. (time frame: Dose-limiting toxicities will be evaluated during the first 28 days of KO-947 monotherapy treatment in the dose escalation portion of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.