Recurrent Colon CancerPhase 1NCT01294826
Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
A Phase 1 study testing AUY922 and Cetuximab in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Swedish Medical Center at 1 site in United States.
Trial summary
The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer
- What is being tested?
- AUY922 and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2015
- 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
- Histologically or cytologically confirmed colorectal cancer
- KRAS wild type metastatic colorectal cancer
- Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
- Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
- Must have at least one measurable lesion
- Must be 18 years of age or older
Show all 9Show fewer
- ECOG performance status 0-1
- Life expectancy must be greater than 12 weeks
- For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion
Who cannot join
- Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
- Metastasis to the CNS
- Prior treatment with any Hsp90 inhibitor compounds
- Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
- Radiotherapy, conventional chemotherapy: within 2 weeks
- Palliative radiotherapy: within 2 weeks
Show all 15Show fewer
- Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
- Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
- Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
- Known sensitivity to cetuximab
- Unresolved ≥ grade 1 diarrhea
- Malignant ascites that require invasive treatment
- Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
- Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
- Impaired cardiac function
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Phase IB With Expansion of Patients at the MTD Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.
- Conditions
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
- Being tested
- AUY922, Cetuximab
- Keywords
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, Cetuximab, HSP90 Heat-Shock Proteins, EGFR protein, human
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
Weekly intravenous infusion on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of AUY922 is 40, 55, and 70 mg/m2 will be used.
CetuximabDrug
Cetuximab will be administered after each AUY922 infusion, intravenously on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression.
| Study group | Role | What they receive |
|---|---|---|
| AUY922 plus Cetuximab | Experimental | Not described Receives: Drug: AUY922; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT)
Measured: 1 cycle (1 cycle = 28 days)
Secondary outcomes (3)
Patient response rate to the AUY922.
Measured: After 2 years
Time to tumor progression following treatment with AUY922.
Measured: After 2 years
Overall survival of patients treated with AUY922.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Colon CancerStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Philip Gold, MD, Principal investigator, Swedish Medical Center Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294826
- Sponsor's protocol ID
- CAUY922AUS06T
- Status last verified
- Jun 2015
- First submitted
- 8 Feb 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB With Expansion of Patients at the MTD Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01294826
- Acronym / sponsor ID
- CAUY922AUS06T
- Conditions
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
- Keywords
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Feb 2011 (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 study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 plus Cetuximab | Experimental | Drug: AUY922, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed colorectal cancer
- KRAS wild type metastatic colorectal cancer
- Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
- Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
- Must have at least one measurable lesion
Key exclusion criteria (15 listed)
- Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
- Metastasis to the CNS
- Prior treatment with any Hsp90 inhibitor compounds
- Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
- Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
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 |
|---|---|---|
| AUY922Weekly intravenous infusion on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of AUY922 is 40, 55, and 70 mg/m2 will be used. | Drug | AUY922 plus Cetuximab |
| CetuximabCetuximab will be administered after each AUY922 infusion, intravenously on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. | Drug | AUY922 plus Cetuximab |
Primary outcome
Incidence of dose limiting toxicity (DLT)
Time frame: 1 cycle (1 cycle = 28 days)
3 secondary outcomes
Patient response rate to the AUY922.
Time frame: After 2 years
Time to tumor progression following treatment with AUY922.
Time frame: After 2 years
Overall survival of patients treated with AUY922.
Time frame: After 2 years
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 8 Jun 2015.
Related trials for Recurrent Colon Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 3
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
Colorectal Neoplasms
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
Colorectal Cancer
RecruitingObservational study
Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
Colorectal Neoplasms
RecruitingPhase 1
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
Metastatic Colorectal Adenocarcinoma, Recurrent Colorectal Adenocarcinoma
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.
Philip Gold, MD principal investigator
Swedish Medical Center Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUY922 and Cetuximab in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Swedish Medical Center at 1 site 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 9 inclusion and 15 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of dose limiting toxicity (DLT) (time frame: 1 cycle (1 cycle = 28 days)). 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 8 Jun 2015.